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Class II · ModerateRecall completed

Penicillamine

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

Does this affect you?
Check your lot numberLot # M200498, Exp. June 2024
Where it was soldProduct was distributed to 3 wholesale/distributor accounts.
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

Failed Dissolution Specifications

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, Nagpur-441 108, India foreign manufacturer
Brand namePENICILLAMINE
Generic namePENICILLAMINE
Active ingredient(s)PENICILLAMINE
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, MD 21202
NDC70748-153-01
Show the full FDA record
Full product labelPenicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed to 3 wholesale/distributor accounts.
QuantityN/A
Recall initiated2023-11-22
Report date2023-12-20
Recall completed2024-07-08
Recall numberD-0148-2024
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.