# FDA recall D-1283-2014

> **Caraco Pharmaceutical Laboratories, Ltd.** · Class II · drug recall initiated 2014-03-20.

## Product

Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), 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 for recall

Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1283-2014
- **Recalling firm:** Caraco Pharmaceutical Laboratories, Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-03-20
- **Report date:** 2014-05-07
- **Termination date:** 2015-02-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Detroit, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1283-2014

## Citation

> AI Analytics. FDA recall D-1283-2014. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-1283-2014. Source: US FDA. Licensed CC0.

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