Recalls / Class II
Class IID-0027-2022
Product
Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06
- Brand name
- Imipramine Pamoate
- Generic name
- Imipramine Pamoate
- Active ingredient
- Imipramine Pamoate
- Route
- Oral
- NDCs
- 68180-314, 68180-315, 68180-316, 68180-317
- FDA application
- ANDA090444
- Affected lot / code info
- lot H002205, exp. date 08/2023
Why it was recalled
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 1,902 bottles
- Distribution pattern
- Distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2021-10-08
- FDA classified
- 2021-10-22
- Posted by FDA
- 2021-10-27
- Terminated
- 2023-03-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0027-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.