Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures
Caraco Pharmaceutical Laboratories is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, because stability results showed the product did not meet drug dissolution specifications.
What this means for you
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 is defined as a situation where use of the product might cause temporary or medically reversible adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a contamination or acute safety defect like a structural failure or toxic substance.
Plain-English summary
Caraco Pharmaceutical Laboratories, Ltd. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg. The recall involves 30-count and 90-count bottles distributed nationwide, including Puerto Rico. The affected lots are JKL5054A, JKM2305A, JKL5054B, and JKM2305B, with expiration dates ranging from August 2014 to March 2015.
The recall was initiated because stability results indicated that the product did not meet the required drug dissolution specifications. This means the tablets may not release the medication in the body as intended.
Consumers and healthcare providers should check their inventory for the specific NDCs (41616-758-83 for 30-count and 41616-758-81 for 90-count) and lot numbers listed above. Affected products should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highwa
- Manufacturer
- Caraco Pharmaceutical Laboratories, Ltd.
- Category
- Drug — Antidepressant
- 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 (6)
- 30 Count Bottle: Lot #: JKL5054A
- Expiry: 08/2014
- Lot #: JKM2305A
- Expiry: 03/2015. 90 Count Bottle: Lot #: JKL5054B
- Lot #: JKM2305B
- Expiry: 03/2015.
Distribution
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