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Recall Observatory FDA recall evidence

Drug product

Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India

D-0236-2015

September 26, 2014

Class II

Product summary

Firm
Sun Pharma Global Inc.
Event
Event 69370
Status
Terminated
Classification
Class II
Quantity
68194
Official record key
drug-enforcement:D-0236-2015

Official wording

Reason: Failed Dissolution Specifications; 12 month stability time point

Code information: Batch Number: JKM3855A Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM3855B Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM7265A Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015 Batch Number: JKM7265B Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications