Micro Labs Recalls Simvastatin Tablets Due to Impurity Failure
Micro Labs USA Inc. is recalling specific lots of Simvastatin Tablets, 20mg, because the product failed a known impurity specification.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
Micro Labs USA Inc. is recalling Simvastatin Tablets, USP, 20mg, in 90-count and 1000-count bottles. The recall affects specific lots with expiration dates in January, February, and March 2015. The product was distributed nationwide.
The recall was initiated because the product failed a known impurity specification. The source text does not specify the exact nature of the impurity or any reported adverse health events.
Consumers with these specific lots should stop using the medication and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- 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 Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540
- Manufacturer
- Micro Labs Usa, Inc S
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: STCG005
- Exp 01/2015
- Lot #: STCG011
- Exp 03/2015
- Lot #: STCG012
- Exp 02/2015.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Micro Labs Usa, Inc S under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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