D-1584-2019 Class III Terminated
FDA drug recall D-1584-2019 was initiated by American Health Packaging on February 19, 2019 and is designated Class III. Reason for recall: CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. The recall status is terminated (terminated September 9, 2020). Affected quantity: 14,360 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 14, 2019
- Initiation Date
- February 19, 2019
- Termination Date
- September 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,360 bottles
Product Description
Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.
Reason for Recall
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Distribution Pattern
Nationwide within the USA and Puerto Rico
Code Information
Lot #: a) G702705 and b) G702706, Exp. 3/31/2020