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Class II · ModerateRecall completed

Imipramine Pamoate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberlot H002205, exp. date 08/2023
Where it was soldDistributed Nationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Out of specification result observed in a dissolution test at the 9-month long term stability time point.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited, Pithampur, (M.P.) 454 775 India foreign manufacturer
Brand nameIMIPRAMINE PAMOATE
Generic nameIMIPRAMINE PAMOATE
Active ingredient(s)IMIPRAMINE PAMOATE
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States
NDC68180-316-06
Show the full FDA record
Full product labelImipramine 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
Recalling firmLupin Pharmaceuticals Inc.
DistributionDistributed Nationwide in the USA.
Quantity1,902 bottles
Recall initiated2021-10-08
Report date2021-10-27
Recall completed2023-03-13
Recall numberD-0027-2022
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.