Penicillamine Tablets Recalled Due to Failed Dissolution Specifications
Lupin Pharmaceuticals is recalling Penicillamine Tablets USP 250 mg (Lot M200498) due to failed dissolution specifications. The affected tablets may not dissolve as intended, potentially affecting drug performance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a quality-specification failure in a pharmaceutical that could affect drug performance, representing a risk of harm. Per the rubric, recalls with theoretical hazards and no reported illness are capped at High severity.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Penicillamine Tablets USP 250 mg in 100-count bottles (NDC 70748-153-01) due to failed dissolution specifications. Lot M200498 is affected; the expiration date is June 2024.
Tablets are required to meet dissolution specifications that ensure proper breakdown in the body. The tablets in this lot failed to meet those specifications, which could affect their performance.
The recalled product was distributed to 3 wholesale/distributor accounts only, limiting the scope of exposure. Consumers or healthcare providers who have this medication should discontinue use of lot M200498.
Patients currently taking Penicillamine from this lot should consult their healthcare provider or pharmacist about obtaining replacement medication.
The recalled product
- Product
- PENICILLAMINE (PENICILLAMINE)
- Brand
- PENICILLAMINE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Tablet Formulation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # M200498
- Exp. June 2024
UPCs (1)
- 0370748153017
Distribution
Distribution scope not specified by the agency.
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