Venlafaxine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failures
Golden State Medical Supply Inc. is recalling 40,631 bottles of Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, due to out-of-specification dissolution results.
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, which typically indicates a situation where use of the product might cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a quality control failure (dissolution) rather than a direct physical danger like fire or choking.
Plain-English summary
Golden State Medical Supply Inc. is recalling 40,631 bottles of Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle. The recall is due to out-of-specification results in retained samples regarding dissolution specifications.
The affected product is identified by NDC # 60429-122-90. The specific lots involved are GS011692 and GS011938 with an expiration date of 10/2017, and GS012638 and GS012639 with an expiration date of 11/2017. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for guidance on alternative treatment options. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 40,631
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 (6)
- Lot #: GS011692
- GS011938
- Exp 10/2017
- GS012638
- GS012639
- Exp 11/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Golden State Medical Supply Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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