Golden State Medical Supply Recalls Aripiprazole Tablets for Dissolution Concerns
Golden State Medical Supply is recalling Aripiprazole 15 mg tablets due to potential out-of-specification dissolution limits.
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 potential out-of-specification dissolution without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Golden State Medical Supply Inc. is recalling Aripiprazole Tablets, 15 mg, 30-count bottles. The recall involves 11,922 bottles distributed nationwide in the USA. The specific lots affected are GS026353, GS027150, GS027653, and GS028044, all with an expiration date of 02/2021.
The recall was initiated because of failed dissolution specifications. There is a possibility that the tablets may have out-of-specification (OOS) dissolution limits for the remaining shelf life. This means the tablets may not dissolve at the required rate, which could affect how the medication is absorbed by the body.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if they have been using the recalled product.
The recalled product
- Product
- ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 11,922
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 #: GS026353
- GS027150
- GS027653
- GS028044
- Exp. Date: 02/2021
Distribution
Distributed nationwide across the United States.
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