Recalls / Class III
Class IIID-0009-2018
Product
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 in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India
- Brand name
- Famotidine
- Generic name
- Famotidine
- Active ingredient
- Famotidine
- Route
- Oral
- NDCs
- 55111-118, 55111-396
- FDA application
- ANDA077367
- Affected lot / code info
- Lot #: a) 79C408882B, 79C408884C, 79C408886B, Exp 10/17; 79C501523B, Exp 01/18; 79C501524B, Exp 01/18; 79C502318B, Exp 3/18; b) 79C408885B, 79C408886A, Exp 10/17; 79C500967, 79C501523C, 79C501525A, 79C501525B, 79C501525C, 79C501526B, Exp 01/18; 79C502317A, Exp 3/18; 79C504087B, 79C504088A, Exp 5/18; 79C505926A, Exp 7/18.
Why it was recalled
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddys Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 569376 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-10-03
- FDA classified
- 2017-10-11
- Posted by FDA
- 2017-10-18
- Terminated
- 2019-03-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0009-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.