Baclofen tablets recalled for presence of foreign tablets or capsules
Golden State Medical Supply Inc. is recalling Baclofen tablets due to the presence of foreign tablets or capsules in bottles. Lot GS065762 affected nationwide.
What this means for you
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 classification applies without reported illnesses or injuries. The presence of foreign tablets or capsules represents a risk of harm, but no injury has been confirmed, placing this at High severity per rubric criteria for contamination without reported harm.
Plain-English summary
Golden State Medical Supply Inc. is recalling Baclofen Tablets USP, 10 mg (NDC 51407-973-10) due to the presence of foreign tablets or capsules in medication bottles. The affected lot is GS065762, which comprises 2472 HDPE bottles distributed nationwide in the United States.
The presence of unidentified tablets or capsules in Baclofen bottles creates a risk of unintended drug exposure. Patients taking this lot may accidentally ingest an unknown substance, potentially causing adverse health effects.
Consumers who have received Baclofen from lot GS065762 should stop using it immediately and consult their healthcare provider or pharmacist. Do not attempt to separate or remove foreign objects from the bottles. Contact Golden State Medical Supply Inc. or the FDA for instructions on returning the product.
The recalled product
- Product
- BACLOFEN (BACLOFEN)
- Brand
- BACLOFEN
- Manufacturer
- Golden State Medical Supply Inc.
- Hazard
- contamination
- foreign-tablets
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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