FDA-Drug2018-01-24Class II

Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.

AVKARE Inc.
Hazard

Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.

Sold states
Nationwide in the USA
Affected count
237 cartons
Manufactured in
615 N 1st St, N/A, Pulaski, TN, United States
Products
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0222-2018

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