Alprazolam Tablets Recalled Due to Potential Cross-Contamination
Golden State Medical Supply Inc. is recalling Alprazolam Tablets, USP 1mg (180-count bottles, Lot #GS027852) due to potential cross-contamination with other drug substances during manufacturing.
What this means for you
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: This is an FDA Class II recall of a prescription drug involving a manufacturing deviation. No illnesses or injuries are reported in the source text, and the hazard is a potential cross-contamination issue identified through quality control, not a confirmed harm event. Under the rubric, Class II recalls without reported illness or injury are classified as Moderate (score 2).
Plain-English summary
Golden State Medical Supply Inc. is recalling Alprazolam Tablets, USP 1mg in 180-count bottles due to a current good manufacturing practice (CGMP) deviation identified during manufacturing. The deviation involved potential cross-contamination with other drug substances during the manufacturing process.
The affected product is Alprazolam Tablets, USP 1mg, NDC 60429-504-18, manufactured by ULTRAlab Laboratories, Inc. (New York) and packaged by GSMS, Inc. (California). The recalled lot is #GS027852 with expiry date 06/2022. A total of 401 bottles were distributed to 1 wholesaler/distributor.
Patients currently taking this medication should contact their healthcare provider or pharmacist before discontinuing use. Healthcare providers should verify whether their patients received product from the recalled lot and take appropriate action if necessary.
The recalled product
- Product
- Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.
- Manufacturer
- Golden State Medical Supply Inc.
- Hazard
- cross-contamination
- manufacturing-deviation
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 #: GS027852
- Expiry: 06/2022.
Distribution
Distribution scope not specified by the agency.
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