FDA Drug recall D-1284-2014
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5)
- FDA Drug
- Class II
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class II recall of Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5) by Caraco Pharmaceutical Laboratories, citing failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1284-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-20 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Caraco Pharmaceutical Laboratories |
| Distribution | US |
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 McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Reason
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Identifiers
| upc | 341616760835 |
|---|---|
| upc | 341616760811 |
| code_info | Lot #: a) JKL4344A, Exp 07/14; JKL5460A, Exp 10/14; JKL5458A, Exp 11/14; b) JKL4344B, Exp 07/14; JKL5460B, Exp 10/14; JKL5458B, Exp 11/14. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1284-2014%22
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