Recalls / Class III
Class IIID-1127-2017
Product
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
- Brand name
- Famotidine
- Generic name
- Famotidine
- Active ingredient
- Famotidine
- Route
- Oral
- NDC
- 68180-150
- FDA application
- ANDA090440
- Affected lot / code info
- Lot #: G606950, Exp 07/18
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 12,888 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-05-02
- FDA classified
- 2017-09-01
- Posted by FDA
- 2017-09-13
- Terminated
- 2018-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1127-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.