Drug recall D-1584-2019
Product
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.
Lots and codes
Lot #: a) G702705 and b) G702706, Exp. 3/31/2020
Recall details
- Recalling firm
- American Health Packaging, Columbus, OH
- Quantity
- 14,360 bottles
- Distribution
- Nationwide within the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 19, 2019
- Terminated
- September 9, 2020
Related products
- Lovastatin – drug information
- NDC 68001-316 Lovastatin · Lovastatin 40 mg/1 · BluePoint Laboratories
- NDC 68001-315 Lovastatin · Lovastatin 20 mg/1 · BluePoint Laboratories
- NDC 68001-314 Lovastatin · Lovastatin 10 mg/1 · BluePoint Laboratories