AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90
Reported: September 12, 2018 Initiated: July 18, 2018 #D-1173-2018
Product Description
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Details
- Recalling Firm
- Avkare Incorporated
- Units Affected
- 12240 bottles
- Distribution
- Nationwide
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90. Recalled by Avkare Incorporated. Units affected: 12240 bottles.
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 September 12, 2018. Severity: Moderate. Recall number: D-1173-2018.
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