The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1284-2014·Announced 2014-05-07

Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failure

Caraco Pharmaceutical Laboratories is recalling 91,777 bottles of Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, because stability results showed the product did not meet drug release 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 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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving a potential quality defect without reported harm.

Plain-English summary

Caraco Pharmaceutical Laboratories, Ltd. is recalling 91,777 bottles of Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg. The affected products are packaged in 30-count bottles (NDC 41616-760-83) and 90-count bottles (NDC 41616-760-81). The recall is due to stability results indicating that the product did not meet the drug release dissolution specifications.

The affected lots include JKL4344A, JKL5460A, and JKL5458A for the 30-count bottles, and JKL4344B, JKL5460B, and JKL5458B for the 90-count bottles. All affected lots have expiration dates of 07/14, 10/14, or 11/14. The products were distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider for further instructions. The recall is classified as FDA Class II, which means the use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah…
Manufacturer
Caraco Pharmaceutical Laboratories, Ltd.
Category
Drug — Antidepressant
Hazard
Affected units
91,777

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 (10)

  • Lot #: a) JKL4344A
  • Exp 07/14
  • JKL5460A
  • Exp 10/14
  • JKL5458A
  • Exp 11/14
  • b) JKL4344B
  • JKL5460B
  • JKL5458B
  • Exp 11/14.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Caraco Pharmaceutical Laboratories, Ltd. 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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