Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
Reported: August 8, 2018 Initiated: July 17, 2018 #D-1021-2018
Product Description
Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 3 HDPE 90-count bottles (270 tablets)
- Distribution
- Product was distributed to 3 medical facilities in Florida.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701. Recalled by RemedyRepack Inc.. Units affected: 3 HDPE 90-count bottles (270 tablets).
Why was this product recalled? ▼
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 8, 2018. Severity: Moderate. Recall number: D-1021-2018.
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