Simvastatin Tablets recall: Impurity Out of Spec
Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs…
Why was Simvastatin Tablets recalled?
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
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 #: STCG005, Exp 01/2015; Lot #: STCG011, Exp 03/2015; Lot #: STCG012, Exp 02/2015.
- Product
- Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs…
- Recalling firm
- Micro Labs Usa, Inc S
- Quantity
- 240 (1000-count bottle), 26,904 (90-count bottle)
- Distribution
- Nationwide.
- Recall date
- March 18, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)