Pfizer Laboratories Div Pfizer Inc

• Diclofenac sodium and misoprostolArthrotec, Dicloenac Sodium and Misoprostol DR · 2 productos
• AxitinibInlyta · 2 productos
• Taliglucerase alfaElelyso · 1 producto
• CrisaboroleEucrisa · 1 producto
• Tranexamic acidCyklokapron · 1 producto
• Diphenoxylate hydrochloride and atropine sulfateLomotil · 1 producto
• MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 1 producto
• EtrasimodVelsipity · 1 producto
• Silver sulfadiazineSsd Cream, Silvadene, Thermazene Silver Sulfadiazine · 1 producto
• Pegfilgrastim-cbqvUdenyca, Stimufend, Neulasta · 1 producto
• RitlecitinibLitfulo · 1 producto
• TrastuzumabOgivri, Kanjinti, Herzuma · 1 producto
• Heparin sodiumHeparin Sodium and Dextrose · 1 producto
• ZavegepantZavzpret · 1 producto
• EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 1 producto
• InfliximabRemicade, Renflexis, Inflectra · 1 producto
• Nafarelin acetateSynarel · 1 producto

2021

1. 15 de marzo de 2021 · Clase II · Cerrado por la FDA · D-0555-2021 · Varenicline tartrate

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56

2. 15 de marzo de 2021 · Clase II · Cerrado por la FDA · D-0557-2021 · Levothyroxine

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01

3. 15 de marzo de 2021 · Clase II · Cerrado por la FDA · D-0556-2021 · Varenicline tartrate

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY 10017

4. 15 de marzo de 2021 · Clase II · Cerrado por la FDA · D-0554-2021 · Varenicline tartrate

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017

5. 15 de marzo de 2021 · Clase II · Cerrado por la FDA · D-0451-2021 · Rimegepant sulfate

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)

2020

1. 27 de febrero de 2020 · Clase II · Cerrado por la FDA · D-0995-2020 · Taliglucerase alfa

   Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.

   Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01

2. 5 de febrero de 2020 · Clase II · Cerrado por la FDA · D-0841-2020 · Amlodipine and atorvastatin

   Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.

   Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30.

3. 5 de febrero de 2020 · Clase II · Cerrado por la FDA · D-0842-2020 · Amlodipine and atorvastatin

   Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.

   Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30.

2018

1. 6 de diciembre de 2018 · Clase II · Cerrado por la FDA · D-0339-2019 · Levothyroxine

   Superpotent Drug.

   Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-01

2. 19 de septiembre de 2018 · Clase II · Cerrado por la FDA · D-0005-2019 · Taliglucerase alfa

   Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.

   Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-01

2016

1. 7 de noviembre de 2016 · Clase II · Cerrado por la FDA · D-0150-2017 · Levothyroxine

   Superpotent

   LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01

2. 9 de septiembre de 2016 · Clase III · Cerrado por la FDA · D-0424-2017 · Misoprostol

   Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months

   Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34

2015

1. 2 de diciembre de 2015 · Clase III · Cerrado por la FDA · D-0520-2016 · Disopyramide phosphate

   Failed Dissolution Specification

   Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Divisio

2014

1. 3 de diciembre de 2014 · Clase II · Cerrado por la FDA · D-0292-2015 · Dofetilide

   Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.

   Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017.

2. 2 de enero de 2014 · Clase III · Cerrado por la FDA · D-745-2014 · Azithromycin

   Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.

   Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-8

2013

1. 4 de septiembre de 2013 · Clase II · Cerrado por la FDA · D-014-2014 · Spironolactone

   Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.

   Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31

2. 31 de mayo de 2013 · Clase III · Cerrado por la FDA · D-607-2013 · Disopyramide phosphate

   Failed Dissolution Specification

   Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Divisio

3. 30 de abril de 2013 · Clase II · Cerrado por la FDA · D-425-2013 · Levothyroxine

   Subpotent Drug: The products were below specification for potency at the expiry stability point.

   Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

4. 30 de abril de 2013 · Clase II · Cerrado por la FDA · D-427-2013 · Levothyroxine

   Subpotent Drug: The products were below specification for potency at the expiry stability point.

   Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC 60793-856-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

5. 30 de abril de 2013 · Clase II · Cerrado por la FDA · D-430-2013 · Levothyroxine

   Subpotent Drug: The products were below specification for potency at the expiry stability point.

   Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC 60793-859-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

6. 30 de abril de 2013 · Clase II · Cerrado por la FDA · D-422-2013 · Levothyroxine

   Subpotent Drug: The products were below specification for potency at the expiry stability point.

   Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

7. 30 de abril de 2013 · Clase II · Cerrado por la FDA · D-428-2013 · Levothyroxine

   Subpotent Drug: The products were below specification for potency at the expiry stability point.

   Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

8. 30 de abril de 2013 · Clase II · Cerrado por la FDA · D-426-2013 · Levothyroxine

   Subpotent Drug: The products were below specification for potency at the expiry stability point.

   Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC 60793-855-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

9. 30 de abril de 2013 · Clase II · Cerrado por la FDA · D-423-2013 · Levothyroxine

   Subpotent Drug: The products were below specification for potency at the expiry stability point.

   Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

10. 30 de abril de 2013 · Clase II · Cerrado por la FDA · D-421-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 60793-850-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

11. 30 de abril de 2013 · Clase II · Cerrado por la FDA · D-431-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC 60793-860-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

12. 30 de abril de 2013 · Clase II · Cerrado por la FDA · D-424-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

13. 30 de abril de 2013 · Clase II · Cerrado por la FDA · D-429-2013 · Levothyroxine

    Subpotent Drug: The products were below specification for potency at the expiry stability point.

    Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

14. 28 de marzo de 2013 · Clase II · Completado · D-257-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened

    Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

15. 28 de marzo de 2013 · Clase II · Completado · D-261-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

16. 28 de marzo de 2013 · Clase II · Completado · D-253-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

17. 28 de marzo de 2013 · Clase II · Completado · D-259-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

18. 28 de marzo de 2013 · Clase II · Completado · D-251-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened..

    Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

19. 28 de marzo de 2013 · Clase II · Completado · D-255-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened..

    Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

20. 28 de marzo de 2013 · Clase II · Completado · D-260-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

21. 28 de marzo de 2013 · Clase II · Completado · D-252-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

22. 28 de marzo de 2013 · Clase II · Completado · D-254-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened..

    Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.,

23. 28 de marzo de 2013 · Clase II · Completado · D-258-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

24. 28 de marzo de 2013 · Clase II · Completado · D-256-2013 · Levothyroxine

    Chemical contamination: emission of strong odor after package was opened.

    Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc.

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).