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.
Reported: August 14, 2019 Initiated: February 19, 2019 #D-1584-2019
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.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 14,360 bottles
- Distribution
- Nationwide within the USA and Puerto Rico
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by American Health Packaging. Units affected: 14,360 bottles.
Why was this product recalled? ▼
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 14, 2019. Severity: Low. Recall number: D-1584-2019.
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