Dr. Reddys Laboratories Limited

2024

1. 2 de enero de 2024 · Clase II · Completado · D-0223-2024 · Tizanidine

   Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.

   Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15

2023

1. 15 de diciembre de 2023 · Clase II · Cerrado por la FDA · D-0219-2024 · Tacrolimus

   Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.

   Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01

2. 13 de octubre de 2023 · Clase II · Cerrado por la FDA · D-0086-2024 · Montelukast

   Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.

   Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.

3. 21 de junio de 2023 · Clase II · En curso · D-0923-2023 · Tizanidine

   Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

   Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10

4. 8 de febrero de 2023 · Clase II · En curso · D-0330-2023 · Tacrolimus

   Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.

   Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.

2022

1. 23 de marzo de 2022 · Clase II · Cerrado por la FDA · D-0737-2022 · Lansoprazole

   Failed Dissolution Specifications; during long term stability testing.

   Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India

2. 23 de marzo de 2022 · Clase II · Cerrado por la FDA · D-0738-2022 · Lansoprazole

   Failed Dissolution Specifications; during long term stability testing.

   Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.

3. 16 de marzo de 2022 · Clase III · Cerrado por la FDA · D-0726-2022 · Atorvastatin

   Failed Impurities/Degradation Specifications: Out of Specification results for related substance.

   Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90

4. 26 de enero de 2022 · Clase II · Cerrado por la FDA · D-0164-2024 · Allopurinol

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

   ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05

2021

1. 19 de julio de 2021 · Clase II · Cerrado por la FDA · D-0750-2021 · Tizanidine

   Failed Tablet/Capsule Specification: Some tablets are shaved

   Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.

2. 4 de junio de 2021 · Clase III · Cerrado por la FDA · D-0629-2021 · Atorvastatin

   Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities

   Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.

3. 4 de mayo de 2021 · Clase III · Cerrado por la FDA · D-0599-2021 · Atorvastatin

   Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities

   Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.

4. 19 de febrero de 2021 · Clase III · Cerrado por la FDA · D-0291-2021 · Atorvastatin

   Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities

   Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA

2019

1. 1 de octubre de 2019 · Clase II · Completado · D-0168-2020 · Ranitidine

   CGMP Deviations: Presence of NDMA impurity detected in product.

   Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)

2. 1 de octubre de 2019 · Clase II · Completado · D-0180-2020 · Ranitidine

   CGMP Deviations: Presence of NDMA impurity detected in product.

   Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)

3. 31 de enero de 2019 · Clase II · Cerrado por la FDA · D-0507-2019 · Divalproex sodium

   Failed Dissolution Specifications: Out of specification results observed for high dissolution.

   Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01

2018

1. 10 de diciembre de 2018 · Clase II · Cerrado por la FDA · D-0294-2019 · Clopidogrel

   Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.

   Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31

2. 7 de noviembre de 2018 · Clase II · Cerrado por la FDA · D-0283-2019 · Clopidogrel

   Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.

   Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31

3. 12 de septiembre de 2018 · Clase III · Cerrado por la FDA · D-0103-2019 · Zoledronic acid

   Failed Impurities/Degradation Specifications: OOS for unknown impurities.

   Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52

4. 4 de septiembre de 2018 · Clase II · Cerrado por la FDA · D-1191-2018 · Tizanidine

   Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .

   Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153

5. 2 de agosto de 2018 · Clase III · Cerrado por la FDA · D-1079-2018 · Atorvastatin

   Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.

   Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05

6. 12 de junio de 2018 · Clase III · Cerrado por la FDA · D-0887-2018 · Atorvastatin

   Failed Impurities/Degradation Specifications

   Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90

7. 12 de junio de 2018 · Clase III · Cerrado por la FDA · D-0886-2018 · Atorvastatin

   Failed Impurities/Degradation Specifications

   Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90

8. 12 de junio de 2018 · Clase III · Cerrado por la FDA · D-0888-2018 · Atorvastatin

   Failed Impurities/Degradation Specifications

   Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA

9. 30 de mayo de 2018 · Clase II · Cerrado por la FDA · D-0878-2018 · Atorvastatin

   Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.

   Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900

10. 23 de abril de 2018 · Clase II · Cerrado por la FDA · D-0727-2018 · Metoprolol

    Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.

    Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01

11. 29 de enero de 2018 · Clase III · Cerrado por la FDA · D-0418-2018 · Atorvastatin

    Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

    Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05

12. 29 de enero de 2018 · Clase III · Cerrado por la FDA · D-0419-2018 · Atorvastatin

    Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

    Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05

13. 29 de enero de 2018 · Clase III · Cerrado por la FDA · D-0420-2018 · Atorvastatin

    Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

    Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05

2017

1. 11 de julio de 2017 · Clase III · Cerrado por la FDA · D-1038-2017 · Pravastatin sodium

   Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.

   Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 IND

2. 22 de mayo de 2017 · Clase II · Cerrado por la FDA · D-0883-2017 · Isotretinoin

   Failed Dissolution Specifications: out of specification results observed for low dissolution.

   Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bac

3. 22 de mayo de 2017 · Clase II · Cerrado por la FDA · D-0885-2017 · Isotretinoin

   Failed Dissolution Specifications: out of specification results observed for low dissolution.

   Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bac

4. 22 de mayo de 2017 · Clase II · Cerrado por la FDA · D-0884-2017 · Isotretinoin

   Failed Dissolution Specifications: out of specification results observed for low dissolution.

   Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bac

5. 22 de mayo de 2017 · Clase II · Cerrado por la FDA · D-0886-2017 · Isotretinoin

   Failed Dissolution Specifications: out of specification results observed for low dissolution.

   Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bac

6. 6 de marzo de 2017 · Clase III · Cerrado por la FDA · D-0649-2017 · Rivastigmine

   Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.

   RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60

7. 15 de febrero de 2017 · Clase III · Cerrado por la FDA · D-0507-2017 · Isotretinoin

   Failed dissolution specifications - low dissolution results at S3 stage.

   Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupa

8. 15 de febrero de 2017 · Clase III · Cerrado por la FDA · D-0509-2017 · Isotretinoin

   Failed dissolution specifications - low dissolution results at S3 stage.

   Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupa

9. 15 de febrero de 2017 · Clase III · Cerrado por la FDA · D-0506-2017 · Isotretinoin

   Failed dissolution specifications - low dissolution results at S3 stage.

   Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachup

2016

1. 28 de diciembre de 2016 · Clase II · Cerrado por la FDA · D-0451-2017 · Fluconazole

   Failed Dissolution Specifications; 18 month stability time point

   Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12

2. 28 de diciembre de 2016 · Clase II · Cerrado por la FDA · D-0449-2017 · Fluconazole

   Failed Dissolution Specifications; 18 month stability time point

   Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India

3. 28 de diciembre de 2016 · Clase II · Cerrado por la FDA · D-0450-2017 · Fluconazole

   Failed Dissolution Specifications; 18 month stability time point

   Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India

4. 28 de diciembre de 2016 · Clase II · Cerrado por la FDA · D-0452-2017 · Fluconazole

   Failed Dissolution Specifications; 18 month stability time point

   Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India

5. 13 de octubre de 2016 · Clase III · Cerrado por la FDA · D-0468-2017 · Olanzapine

   Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.

   Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30

6. 29 de agosto de 2016 · Clase III · Cerrado por la FDA · D-0098-2017 · Isotretinoin

   Failed Dissolution Specifications

   ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 5

7. 3 de junio de 2016 · Clase III · Cerrado por la FDA · D-1063-2016 · Sirolimus

   Failed impurities/degradation: out of specification result for impurity secorapamycin.

   Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01

8. 3 de marzo de 2016 · Clase II · Cerrado por la FDA · D-0784-2016 · Zoledronic acid

   Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial

   Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52

2015

1. 4 de noviembre de 2015 · Clase III · Cerrado por la FDA · D-0719-2016 · Paricalcitol

   Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

   Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30

2. 4 de noviembre de 2015 · Clase III · Cerrado por la FDA · D-0720-2016 · Paricalcitol

   Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

   Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30

3. 4 de noviembre de 2015 · Clase III · Cerrado por la FDA · D-0721-2016 · Paricalcitol

   Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

   Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30

4. 3 de agosto de 2015 · Clase II · Cerrado por la FDA · D-1325-2015 · Rivastigmine

   Failed Dissolution Specifications

   Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60

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).