Dr. Reddy's Laboratories, Inc.

FDA Drug Class III Terminated

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.

September 12, 2018 Dr. Reddy's Laboratories, Inc. 59,468 vials units

FDA Drug Class II Terminated

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

September 4, 2018 Dr. Reddy's Laboratories, Inc. 8376 units units

FDA Drug Class III Terminated

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

August 2, 2018 Dr. Reddy's Laboratories, Inc. 2280 bottles units

FDA Drug Class III Terminated

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

June 12, 2018 Dr. Reddy's Laboratories, Inc. 44,894 bottles units

FDA Drug Class III Terminated

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

June 12, 2018 Dr. Reddy's Laboratories, Inc. 55,126 bottles units

FDA Drug Class III Terminated

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

June 12, 2018 Dr. Reddy's Laboratories, Inc. 130,081 bottles units

FDA Drug Class II Terminated

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

May 30, 2018 Dr. Reddy's Laboratories, Inc. 6,397 bottles units

FDA Drug Class II Terminated

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

April 23, 2018 Dr. Reddy's Laboratories, Inc. 8160 bottles units

FDA Drug Class III Terminated

Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-

March 8, 2018 Dr. Reddy's Laboratories, Inc. 4,152 tubes units

FDA Drug Class III Terminated

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

January 29, 2018 Dr. Reddy's Laboratories, Inc. 12,579 bottles units

FDA Drug Class III Terminated

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

January 29, 2018 Dr. Reddy's Laboratories, Inc. a) 28,941 and b) 2,928 bottles units

FDA Drug Class III Terminated

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

January 29, 2018 Dr. Reddy's Laboratories, Inc. a) 34,125; b) 3,540 bottles units

FDA Drug Class III Terminated

Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023

October 30, 2017 Dr. Reddy's Laboratories, Inc. 23402 cases units

FDA Drug Class III Terminated

Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made

October 3, 2017 Dr. Reddy's Laboratories, Inc. 569376 bottles units

FDA Drug Class III Terminated

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, Bach

July 11, 2017 Dr. Reddy's Laboratories, Inc. 544 bottles units

FDA Drug Class II Terminated

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

May 22, 2017 Dr. Reddy's Laboratories, Inc. 13,221 cartons units

FDA Drug Class II Terminated

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

May 22, 2017 Dr. Reddy's Laboratories, Inc. 452,290 cartons units

FDA Drug Class II Terminated

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

May 22, 2017 Dr. Reddy's Laboratories, Inc. 223,650 cartons units

FDA Drug Class II Terminated

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

May 22, 2017 Dr. Reddy's Laboratories, Inc. 89,118 cartons units

FDA Drug Class III Terminated

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

March 6, 2017 Dr. Reddy's Laboratories, Inc. 1,728 bottles units

FDA Drug Class III Terminated

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

February 15, 2017 Dr. Reddy's Laboratories, Inc. 4032 cartons units

FDA Drug Class III Terminated

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

February 15, 2017 Dr. Reddy's Laboratories, Inc. 12132 cartons units

FDA Drug Class III Terminated

Zenatane (isotretinoin) capsules, 30 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

February 15, 2017 Dr. Reddy's Laboratories, Inc. 4014 cartons units

FDA Drug Class III Terminated

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

February 15, 2017 Dr. Reddy's Laboratories, Inc. 4404 cartons units

FDA Drug Class II Terminated

Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11

January 9, 2017 Dr. Reddy's Laboratories, Inc. 1,051 vials units

FDA Drug Class II Terminated

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

December 28, 2016 Dr. Reddy's Laboratories, Inc. a) 2472 bottles, b) 780 bottles units

FDA Drug Class II Terminated

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

December 28, 2016 Dr. Reddy's Laboratories, Inc. a) 38,832 and b) 5,064 bottles units

FDA Drug Class II Terminated

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

December 28, 2016 Dr. Reddy's Laboratories, Inc. a) 42,984 and b) 7,764 bottles units

FDA Drug Class II Terminated

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

December 28, 2016 Dr. Reddy's Laboratories, Inc. 59,440 blister cards units

FDA Drug Class III Terminated

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

October 13, 2016 Dr. Reddy's Laboratories, Inc. 5,904 bottles units

FDA Drug Class III Terminated

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

August 29, 2016 Dr. Reddy's Laboratories, Inc. 3,858 prescription packs (115,680 capsules) units

FDA Drug Class III Terminated

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

June 3, 2016 Dr. Reddy's Laboratories, Inc. 9,330 bottles units

FDA Drug Class III Terminated

CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523

April 22, 2016 Dr. Reddy's Laboratories, Inc. 84,240 bottles units

FDA Drug Class II Terminated

Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30

March 30, 2016 Dr. Reddy's Laboratories, Inc. 50,280 bottles units

FDA Drug Class II Terminated

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

March 3, 2016 Dr. Reddy's Laboratories, Inc. 3,342 vials units

FDA Drug Class III Terminated

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

November 4, 2015 Dr. Reddy's Laboratories, Inc. 4383 bottles units

FDA Drug Class III Terminated

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

November 4, 2015 Dr. Reddy's Laboratories, Inc. 9,155 bottles units

FDA Drug Class III Terminated

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

November 4, 2015 Dr. Reddy's Laboratories, Inc. 11,123 bottles units

FDA Drug Class III Terminated

Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's

August 13, 2015 Dr. Reddy's Laboratories, Inc. a) 16,080 and b) 480 Bottles units

FDA Drug Class III Terminated

Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's

August 13, 2015 Dr. Reddy's Laboratories, Inc. a) 14,640 and b) 624 Bottles units

FDA Drug Class III Terminated

Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's

August 13, 2015 Dr. Reddy's Laboratories, Inc. a) 16,848 and b) 216 Bottles units

FDA Drug Class III Terminated

Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-320-30.

August 13, 2015 Dr. Reddy's Laboratories, Inc. 576 Bottles units

FDA Drug Class III Terminated

Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-313-30.

August 13, 2015 Dr. Reddy's Laboratories, Inc. 3840 Bottles units

FDA Drug Class III Terminated

Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-317-30.

August 13, 2015 Dr. Reddy's Laboratories, Inc. 984 Bottles units

FDA Drug Class III Terminated

Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-323-30.

August 13, 2015 Dr. Reddy's Laboratories, Inc. 1,056 Bottles units

FDA Drug Class II Terminated

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

August 3, 2015 Dr. Reddy's Laboratories, Inc. 2,952 bottles units

FDA Drug Class II Terminated

Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01

May 22, 2015 Dr. Reddy's Laboratories, Inc. 5,160 bottles units

FDA Drug Class II Terminated

Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Lim

May 22, 2015 Dr. Reddy's Laboratories, Inc. 100 count 7479; 500 count - 2544 units

FDA Drug Class III Terminated

Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90

May 6, 2015 Dr. Reddy's Laboratories, Inc.

FDA Drug Class III Terminated

Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's Laboratori

May 6, 2015 Dr. Reddy's Laboratories, Inc.