Lovastatin Tablets USP recall: Impurity Out of Spec
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.
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) G702755, Exp March 2020; b) G702756, Exp March 2020
- Product
- Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA.
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 44,640 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Recall date
- February 27, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)