Class II
Terminated
Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
This recall has been terminated (originally issued August 8, 2018).
- Company
- Remedyrepack Inc.
- Recall Initiated
- July 17, 2018
- Posted
- August 8, 2018
- Recall Number
- D-1021-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3 HDPE 90-count bottles (270 tablets)
- Firm Location
- Indiana, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution
Product was distributed to 3 medical facilities in Florida.
Lot / Code Info
Lot # B0383153-122917; Exp. 12/18
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