Recalls / Class III
Class IIID-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.
- Brand name
- Lovastatin
- Generic name
- Lovastatin
- Active ingredient
- Lovastatin
- Route
- Oral
- NDCs
- 68001-314, 68001-315, 68001-316
- FDA application
- ANDA078296
- Affected lot / code info
- Lot #: a) G702705 and b) G702706, Exp. 3/31/2020
Why it was recalled
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Recalling firm
- Firm
- American Health Packaging
- Manufacturer
- BluePoint Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 14,360 bottles
- Distribution pattern
- Nationwide within the USA and Puerto Rico
Timeline
- Recall initiated
- 2019-02-19
- FDA classified
- 2019-08-02
- Posted by FDA
- 2019-08-14
- Terminated
- 2020-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1584-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.