Actavis Pharma, Inc.

• BosentanTracleer · 2 productos
• LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 2 productos
• AllopurinolAloprim · 2 productos
• Minoxidil2 productos
• LactuloseKristalose, Lactulose Crystalline, Enulose · 2 productos
• TemazepamRestoril · 2 productos
• Indapamide2 productos
• GlipizideGlucotrol XL · 2 productos
• Dicyclomine hydrochloride2 productos
• NabumetoneRelafen Ds · 2 productos
• Solifenacin succinate2 productos
• Memantine hydrochloride2 productos
• Promethazine hydrochloridePhenergan, Promethegan · 2 productos
• Isosorbide mononitrate2 productos
• Diclofenac sodium and misoprostolArthrotec, Dicloenac Sodium and Misoprostol DR · 2 productos
• CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 2 productos
• Atenolol and chlorthalidone2 productos
• Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 2 productos
• HydrochlorothiazideInzirqo · 2 productos
• Triamterene and hydrochlorothiazide2 productos
• Nizatidine2 productos
• AcyclovirZovirax, Avaclyr · 2 productos
• Trihexyphenidyl hydrochloride2 productos
• Sulindac2 productos
• Pilocarpine hydrochlorideSalagen, Qlosi · 2 productos
• Buprenorphine and naloxoneZubsolv, Buprenorphine and Naloxone Sublingual Film, Suboxone · 2 productos
• Tamoxifen citrateSoltamox · 2 productos
• Fluvoxamine maleate2 productos
• Butalbital, acetaminophen, caffeine and codeine phosphate2 productos
• RamelteonRozerem · 1 producto
• AlbendazoleAlbenza · 1 producto
• LevalbuterolXopenex HFA · 1 producto
• PenicillamineAagylur, Depen, Cuprimine · 1 producto
• PrimidoneMysoline · 1 producto
• Tranylcypromine sulfateParnate · 1 producto
• Vinorelbine1 producto
• Azelaic acidFinacea Foam, Azelex · 1 producto
• Clarithromycin1 producto
• BexaroteneTargretin · 1 producto
• Orphenadrine citrate1 producto
• TretinoinRetin-A, Retin-A Micro, Altreno · 1 producto
• NystatinNystop, Klayesta, Nyamyc · 1 producto
• Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 1 producto
• DesoximetasoneTopicort · 1 producto
• Clindamycin phosphate and tretinoinZiana · 1 producto
• Pentazocine hydrochloride and naloxone hydrochloride1 producto
• Trospium chloride1 producto
• VigabatrinSabril, Vigadrone, Vigafyde · 1 producto
• Fluocinolone acetonideFluocinolone Acetonide Oil, Derma-Smoothe/Fs, Synalar · 1 producto
• GriseofulvinUltramicrosize Griseofulvin, Griseofulvin Microsize · 1 producto
• HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 1 producto
• DesonideTridesilon Cream · 1 producto
• Valproic acid1 producto
• SildenafilViagra, Vybrique, Revatio · 1 producto
• Probenecid and colchicine1 producto
• Metaxalone1 producto
• BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 1 producto
• UrsodiolReltone 200 Mg, Ursolign, Urso Forte · 1 producto
• ScopolamineScopolamine Trandermal System, Transderm Scop · 1 producto
• Pimecrolimus1 producto
• IvermectinStromectol, Soolantra · 1 producto
• FosaprepitantFocinvez, Emend, Navitrux · 1 producto
• MifepristoneKorlym · 1 producto
• MiconazoleOravig · 1 producto
• Doxylamine succinate and pyridoxine hydrochlorideDiclegis, Bonjesta · 1 producto
• DalfampridineAmpyra · 1 producto
• ValganciclovirValcyte · 1 producto
• Fludarabine phosphate1 producto
• AdapaleneDifferin · 1 producto
• LevetiracetamKeppra, Spritam, Keppra XR · 1 producto
• Ciclopirox1 producto
• Chlorzoxazone1 producto
• Hydroxocobalamin (hydroxocobalamin acetate)1 producto
• Tranexamic acidCyklokapron · 1 producto
• Minocycline hydrochlorideArestin, Zilxi, Amzeeq · 1 producto
• Doxorubicin hydrochlorideDoxil, Doxorubicin Hydrochloride Liposome · 1 producto
• IbuprofenIbu, Caldolor · 1 producto
• Alvimopan1 producto
• Probenecid1 producto
• Irinotecan hydrochlorideCamptosar, Onivyde · 1 producto
• TopotecanHycamtin · 1 producto
• Clotrimazole and betamethasone dipropionate1 producto

2024

1. 8 de agosto de 2024 · Clase II · En curso · D-0637-2024 · Testosterone

   Superpotent Drug

   Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30

2. 28 de marzo de 2024 · Clase II · En curso · D-0439-2024 · Isotretinoin

   Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

   Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15

3. 8 de enero de 2024 · Clase II · En curso · D-0275-2024 · Budesonide

   Failed Dissolution Specifications

   Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2

2023

1. 10 de noviembre de 2023 · Clase III · Cerrado por la FDA · D-0127-2024 · Testosterone

   OOS for viscosity

   Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30

2022

1. 21 de julio de 2022 · Clase II · Cerrado por la FDA · D-1302-2022 · Diltiazem

   Failed Dissolution Specifications: below specification limits for dissolution.

   Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsip

2. 29 de junio de 2022 · Clase II · Cerrado por la FDA · D-1289-2022 · Testosterone

   Superpotent Drug: Out of specification assay result was obtained during stability testing.

   Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharm

3. 13 de abril de 2022 · Clase II · Cerrado por la FDA · D-1067-2022 · Levalbuterol

   cGMP deviations: Temperature abuse

   Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 0591-2927-54

4. 13 de abril de 2022 · Clase II · Cerrado por la FDA · D-1068-2022 · Lidocaine

   cGMP deviations: Temperature abuse

   Lidocaine Patch 5%, 30-count box, Rx only, MFG: Teva Pharma USA, NDC 0591-3525-30

5. 26 de enero de 2022 · Clase II · Cerrado por la FDA · D-0175-2024 · Dicyclomine hydrochloride

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01

6. 26 de enero de 2022 · Clase II · Cerrado por la FDA · D-0191-2024 · Metoprolol

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96

7. 18 de enero de 2022 · Clase II · Cerrado por la FDA · D-0461-2022 · Doxylamine succinate and pyridoxine hydrochloride

   Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient

   Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Ph

2021

1. 28 de octubre de 2021 · Clase III · Cerrado por la FDA · D-0235-2022 · Clonidine

   Failed Impurities/Degradation Specifications

   Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04

2. 27 de octubre de 2021 · Clase II · Cerrado por la FDA · D-0232-2022 · Diltiazem

   Labelling: Incorrect Exp. Date

   Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laborat

3. 15 de marzo de 2021 · Clase II · Cerrado por la FDA · D-0580-2021 · Levalbuterol

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

4. 15 de marzo de 2021 · Clase II · Cerrado por la FDA · D-0581-2021 · Desvenlafaxine

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30 Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

2020

1. 11 de noviembre de 2020 · Clase III · Cerrado por la FDA · D-0100-2021 · Testosterone

   Superpotent Drug: High out-of-specification assay results were obtained during stability testing.

   Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt L

2. 28 de octubre de 2020 · Clase II · Cerrado por la FDA · D-0069-2021 · Mesalamine

   Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.

   Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, ND

3. 14 de julio de 2020 · Clase II · Cerrado por la FDA · D-1492-2020 · Lidocaine

   Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.

   Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30

4. 20 de febrero de 2020 · Clase II · Cerrado por la FDA · D-0862-2020 · Mesalamine

   Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.

   Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 059

5. 27 de enero de 2020 · Clase II · Cerrado por la FDA · D-0837-2020 · Methylphenidate

   CGMP deviations: Product bottle may be absent of desiccant.

   Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01

6. 27 de enero de 2020 · Clase II · Cerrado por la FDA · D-0836-2020 · Methylphenidate

   CGMP deviations: Product bottle may be absent of desiccant.

   Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01

2019

1. 4 de noviembre de 2019 · Clase II · Cerrado por la FDA · D-0518-2020 · Valganciclovir

   Presence of foreign substance: Brown/black particles found during stability testing.

   Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany

2. 6 de septiembre de 2019 · Clase III · Cerrado por la FDA · D-0131-2020 · Diltiazem

   GMP Deviation: lot not intended for commercial distribution.

   Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ ND

2018

1. 5 de julio de 2018 · Clase II · Cerrado por la FDA · D-0909-2018 · Fluocinolone acetonide

   Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.

   Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, N

2. 30 de abril de 2018 · Clase III · Cerrado por la FDA · D-0857-2018 · Lidocaine

   Failed Stability Specifications

   Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)

2016

1. 11 de julio de 2016 · Clase II · Cerrado por la FDA · D-1448-2016 · Dextroamphetamine

   Failed Dissolution Specifications

   Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 4596

2015

1. 10 de febrero de 2015 · Clase II · Cerrado por la FDA · D-0395-2015 · Dextroamphetamine

   Failed Dissolution Specifications

   Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC

2014

1. 15 de diciembre de 2014 · Clase II · Cerrado por la FDA · D-0337-2015 · Gabapentin

   Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

   Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110,

2. 15 de diciembre de 2014 · Clase II · Cerrado por la FDA · D-0338-2015 · Gabapentin

   Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

   Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108

3. 15 de diciembre de 2014 · Clase II · Cerrado por la FDA · D-0336-2015 · Gabapentin

   Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

   Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108

4. 26 de septiembre de 2014 · Clase II · Cerrado por la FDA · D-0258-2015 · Diclofenac sodium and misoprostol

   Failed Tablet/Capsule Specifications: Presence of split or broken tablets.

   Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6.

5. 24 de abril de 2014 · Clase II · Cerrado por la FDA · D-1616-2014 · Diclofenac sodium and misoprostol

   Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

   Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.

6. 24 de abril de 2014 · Clase II · Cerrado por la FDA · D-1617-2014 · Diclofenac sodium and misoprostol

   Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

   Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.

7. 10 de febrero de 2014 · Clase II · Cerrado por la FDA · D-1153-2014 · Alprazolam

   Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.

   Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50

2013

1. 20 de diciembre de 2013 · Clase II · Cerrado por la FDA · D-1082-2014 · Diclofenac sodium and misoprostol

   Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

   Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.

2. 15 de noviembre de 2013 · Clase III · Cerrado por la FDA · D-1043-2014 · Bupropion

   Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.

   BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laborato

3. 9 de octubre de 2013 · Clase II · Cerrado por la FDA · D-018-2014 · Alprazolam

   Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets

   Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11

4. 22 de marzo de 2013 · Clase II · Cerrado por la FDA · D-817-2013 · Diclofenac sodium and misoprostol

   Failed Tablet/Capsule Specifications: Broken tablets

   Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60

5. 22 de marzo de 2013 · Clase II · Cerrado por la FDA · D-1060-2014 · Diclofenac sodium and misoprostol

   Failed Tablet/Capsule Specifications: Broken tablets

   Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)

6. 13 de febrero de 2013 · Clase III · Cerrado por la FDA · D-190-2013 · Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

   Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.

   Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200

2012

1. 17 de abril de 2012 · Clase III · Cerrado por la FDA · D-1402-2012 · Loxapine

   Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

   Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01

2. 17 de abril de 2012 · Clase III · Cerrado por la FDA · D-1401-2012 · Loxapine

   Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

   Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01

3. 17 de abril de 2012 · Clase III · Cerrado por la FDA · D-1400-2012 · Loxapine

   Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

   Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01

Clase I: El tipo más grave: existe una probabilidad razonable de que usar el producto cause problemas de salud graves o la muerte.
Clase II: Usar el producto puede causar problemas de salud temporales o reversibles con tratamiento, o la probabilidad de problemas graves es remota.
Clase III: No es probable que usar el producto cause problemas de salud (por ejemplo, un problema de etiquetado o de envase).