Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
Reported: January 24, 2018 Initiated: January 3, 2018 #D-0222-2018
Product Description
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
Reason for Recall
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- 237 cartons
- Distribution
- Nationwide in the USA
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.. Recalled by AVKARE Inc.. Units affected: 237 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 24, 2018. Severity: Moderate. Recall number: D-0222-2018.
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