Why it was recalled
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Product description
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
Lot numbers, UPCs & expiration codes
lot H002205, exp. date 08/2023
Where it was sold
Distributed Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0027-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 8, 2021
- FDA report date
- Oct 27, 2021
- Quantity
- 1,902 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0027-2022, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 88838
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- lot H002205, exp. date 08/2023
- Postal code
- 21202-6174
- Report date
- Oct 27, 2021
- Product type
- Drugs
- Recall number
- D-0027-2022
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 1,902 bottles
- Termination date
- Mar 13, 2023
- Reason for recall
- Out of specification result observed in a dissolution test at the 9-month long term stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the USA.
- Recall initiation date
- Oct 8, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 22, 2021