Class III
Terminated
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.
This recall has been terminated (originally issued August 14, 2019).
- Company
- American Health Packaging
- Recall Initiated
- February 19, 2019
- Posted
- August 14, 2019
- Recall Number
- D-1584-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,360 bottles
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Distribution
Nationwide within the USA and Puerto Rico
Lot / Code Info
Lot #: a) G702705 and b) G702706, Exp. 3/31/2020
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