Dr. Reddys Laboratories Limited

2024

1. January 2, 2024 · Class II · Completed · 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. December 15, 2023 · Class II · Terminated · 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. October 13, 2023 · Class II · Terminated · 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. June 21, 2023 · Class II · Ongoing · 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. February 8, 2023 · Class II · Ongoing · 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. March 23, 2022 · Class II · Terminated · 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. March 23, 2022 · Class II · Terminated · 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. March 16, 2022 · Class III · Terminated · 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. January 26, 2022 · Class II · Terminated · 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. July 19, 2021 · Class II · Terminated · 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. June 4, 2021 · Class III · Terminated · 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. May 4, 2021 · Class III · Terminated · 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. February 19, 2021 · Class III · Terminated · 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. October 1, 2019 · Class II · Completed · 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. October 1, 2019 · Class II · Completed · 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. January 31, 2019 · Class II · Terminated · 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. December 10, 2018 · Class II · Terminated · 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. November 7, 2018 · Class II · Terminated · 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. September 12, 2018 · Class III · Terminated · 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. September 4, 2018 · Class II · Terminated · 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. August 2, 2018 · Class III · Terminated · 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. June 12, 2018 · Class III · Terminated · 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. June 12, 2018 · Class III · Terminated · 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. June 12, 2018 · Class III · Terminated · 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. May 30, 2018 · Class II · Terminated · 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. April 23, 2018 · Class II · Terminated · 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. January 29, 2018 · Class III · Terminated · 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. January 29, 2018 · Class III · Terminated · 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. January 29, 2018 · Class III · Terminated · 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. July 11, 2017 · Class III · Terminated · 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. May 22, 2017 · Class II · Terminated · 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. May 22, 2017 · Class II · Terminated · 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. May 22, 2017 · Class II · Terminated · 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. May 22, 2017 · Class II · Terminated · 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. March 6, 2017 · Class III · Terminated · 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. February 15, 2017 · Class III · Terminated · 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. February 15, 2017 · Class III · Terminated · 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. February 15, 2017 · Class III · Terminated · 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. December 28, 2016 · Class II · Terminated · 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. December 28, 2016 · Class II · Terminated · 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. December 28, 2016 · Class II · Terminated · 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. December 28, 2016 · Class II · Terminated · 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. October 13, 2016 · Class III · Terminated · 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. August 29, 2016 · Class III · Terminated · 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. June 3, 2016 · Class III · Terminated · 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. March 3, 2016 · Class II · Terminated · 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. November 4, 2015 · Class III · Terminated · 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. November 4, 2015 · Class III · Terminated · 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. November 4, 2015 · Class III · Terminated · 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. August 3, 2015 · Class II · Terminated · 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

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).