Reported Oct 18, 2017 · Terminated
Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC…
Dr. Reddy's Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30
- Distributed byCVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30
- Distributed byWal-Mart Stores, Inc. Bentonville, AR 72716, Made in India
- Lot codes and dates
Lot #: a) 79C408882B79C408884C79C408886BExp 10/1779C501523BExp 01/1879C501524BExp 01/1879C502318BExp 3/18b) 79C408885B79C408886AExp 10/1779C50096779C501523C79C501525A79C501525B79C501525C79C501526BExp 01/1879C502317AExp 3/1879C504087B79C504088AExp 5/1879C505926AExp 7/18
- Amount recalled
- 569376 bottles
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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