Famotidine for Oral Suspension USP recalled over manufacturing violations
- Recall date
- May 2, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Lupin Pharmaceuticals Inc. recalls Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., B…
- Recall number
- D-1127-2017
- FDA classification
- Class III
- Brand / firm
- Lupin Pharmaceuticals Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviations
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01
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