Baclofen tablet bottles recalled over the presence of foreign tablets
Golden State Medical Supply is recalling 2,472 bottles of Baclofen Tablets USP, 10 mg, over the presence of foreign tablets or capsules.
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: Scored 3 under the risk-of-harm criterion: foreign tablets or capsules in a prescription bottle can lead to a patient taking the wrong medicine, and no injuries are reported.
Plain-English summary
Baclofen Tablets USP, 10 mg, in 1000-count bottles, marketed by GSMS, Incorporated of California under NDC 51407-973-10, are being recalled.
The reason given in the enforcement record is the presence of foreign tablets or capsules.
The recall covers 2,472 HDPE bottles from lot GS065762. Distribution was nationwide within the USA. The FDA has classified the action as Class II.
A bottle containing another product's tablets or capsules can result in a patient taking a medicine that was not prescribed to them. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- BACLOFEN (BACLOFEN)
- Brand
- BACLOFEN
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Muscle relaxant
- Affected units
- 2,472
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 (1)
- Lot GS065762
Distribution
Distributed nationwide across the United States.
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