D-0222-2018 Class II Terminated
FDA drug recall D-0222-2018 was initiated by AVKARE Inc. on Jan 3, 2018 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing. The recall status is terminated (terminated May 8, 2020). Affected quantity: 237 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 24, 2018
- Initiation Date
- Jan 3, 2018
- Termination Date
- May 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 237 cartons
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 15270, Exp. 01/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0222-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026