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
Reported: October 27, 2021 Initiated: October 8, 2021 #D-0027-2022
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
Reason for Recall
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 1,902 bottles
- Distribution
- Distributed Nationwide in the USA.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 1,902 bottles.
Why was this product recalled? ▼
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 27, 2021. Severity: Moderate. Recall number: D-0027-2022.
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