The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1458-2016·Announced 2016-08-24

Golden State Medical Supply Recalls Venlafaxine Hydrochloride Extended-Release Capsules

Golden State Medical Supply Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, due to failed dissolution specifications.

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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly for pharmaceutical products where efficacy is compromised.

Plain-English summary

Golden State Medical Supply Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg. The recall involves 65,401 bottles distributed nationwide. The affected products are identified by specific NDC numbers and lot numbers listed in the recall notice.

The recall was initiated because retained samples failed to meet dissolution specifications, resulting in out-of-specification results. This means the capsules may not release the medication as intended.

Consumers with these specific products should contact their healthcare provider or pharmacist for guidance on how to proceed. The recall is classified as FDA Class II.

The recalled product

Product
Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
65,401

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 (15)

  • Lot #: a) GS011931
  • Exp 10/2017
  • GS011932
  • Exp 11/2017 b) GS010773
  • GS011242
  • 09/2017
  • GS011061
  • GS011315
  • GS011357
  • GS011585
  • GS011586
  • GS011588
  • GS011591
  • GS011933
  • 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.

See all 2 products in this recall →

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