Recalls / Class II
Class IID-1146-2014
Product
a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 d) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 28 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 e) Equate Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer, 14 capsules per Bottle, and 28 capsules per bottle (Twin Pack)Distributed by Wal-mart Stores Inc. Bentonville, AR 72716 f) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 42 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895
- Affected lot / code info
- Lot #: a) 79305114A, b) 79305114B, c) 79305114C, d) 79305114D, e) 79305114E, f) 79305114F, Exp 05/2015
Why it was recalled
Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 58,656 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-01-03
- FDA classified
- 2014-03-05
- Posted by FDA
- 2014-03-12
- Terminated
- 2015-11-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1146-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.