Class I · High risk Ongoing
Famotidine Injection
Reason Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Famotidine Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
What was recalled
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
- Recalling firm
- Mylan Pharmaceuticals Inc.
- NDC code
- 0378-3020-01
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1703-2012
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Famotidine recalls
See all
Class II · Moderate risk Ongoing
Ibuprofen and Famotidine Tablets 800mg/26.6mg
Reason Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class II · Moderate risk Terminated
Famotidine Tablets
Reason Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Class II · Moderate risk Terminated
Famotidine Tablets USP 40mg
Reason Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Class III · Low risk Terminated
Famotidine Injection
Reason TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
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