Golden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
Golden State Medical Supply is recalling 1,200 bottles of Carbamazepine 200mg tablets due to tablets containing black specks.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves CGMP deviations (black specks) without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Golden State Medical Supply Inc. is recalling 1,200 bottles of Carbamazepine Tablets, USP, 200mg. The product is marketed by GSMS, Incorporated, in Camarillo, CA, and manufactured by Taro Pharmaceutical Industries Ltd. The recall covers 100-count and 1,000-count bottles distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of black specks in the tablets. Affected lots include GS067429, GS068091, GS067430, and GS068090, all with an expiration date of May 31, 2028.
Consumers and healthcare providers should check their inventory for the specific NDCs (51407-215-10 and 51407-215-01) and lot numbers listed above. If the product is found, it should be quarantined and not administered to patients.
The recalled product
- Product
- CARBAMAZEPINE (CARBAMAZEPINE)
- Brand
- CARBAMAZEPINE
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 1,200
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 (5)
- Lot #: a) GS067429
- GS068091
- Exp 5/31/2028
- b) GS067430
- GS068090
Distribution
Distributed nationwide across the United States.
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