Recalls / Class II
Class IID-0222-2018
Product
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
- Affected lot / code info
- Lot: 15270, Exp. 01/18
Why it was recalled
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 237 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-01-03
- FDA classified
- 2018-01-12
- Posted by FDA
- 2018-01-24
- Terminated
- 2020-05-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0222-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.