June 2014 FDA Recall Drug by Caraco Pharmaceutical Laboratories, Ltd.
D-1415-2014 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Caraco Pharmaceutical Laboratories, Ltd. on June 12, 2014 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1415-2014

Reason for Recall
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Initiated
06-12-2014
Reported
07-09-2014
Quantity
26,530 30-Count Bottles; 14,597 90-Count Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68637
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Caraco Pharmaceutical Laboratories, Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide including Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-06-2015
Product Description About Product Description
Full technical description of the 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 Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81.

Batch or Lot Expiration Information

Lot# 30 Count Bottle:
Lot# : JKL5054A, Expiry: 08/2014
Lot# : JKM2305A, Expiry: 03/2015. 90 Count Bottle:
Lot# : JKL5054B, Expiry: 08/2014
Lot# : JKM2305B, Expiry: 03/2015.