Lovastatin Tablets USP recall: Impurity Out of Spec
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.
Why was Lovastatin Tablets USP recalled?
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) G702705 and b) G702706, Exp. 3/31/2020
- 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.
- Recalling firm
- American Health Packaging
- Quantity
- 14,360 bottles
- Distribution
- Nationwide within the USA and Puerto Rico
- Recall date
- August 14, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)