Golden State Medical Supply Recalls Omeprazole Capsules Due to Impurities
Golden State Medical Supply is recalling Omeprazole Delayed Release Capsules because stability testing revealed unknown impurities.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score according to the rubric.
Plain-English summary
Golden State Medical Supply Inc. is recalling Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles. The product is prescription-only and is identified by NDC 51407-129-10. The specific lot affected is GS029673, with an expiration date of 5/2021.
The recall was initiated because the manufacturer obtained out-of-specification results for unknown impurities during stability testing. This indicates that the product failed to meet required impurities and degradation specifications.
The affected product was sold to two wholesalers and distributors located in Pennsylvania and Texas under government contract. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or return.
The recalled product
- Product
- Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Prescription Medication
- 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 #: GS029673
- Exp. Date 5/2021
Distribution
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