Micro Labs Recalls Simvastatin Tablets Due to Impurity Specification Failure
Micro Labs USA Inc. is recalling 1,008 bottles of Simvastatin Tablets, 10 mg, because the product failed impurity content specifications.
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 FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Micro Labs USA Inc. is recalling 1,008 bottles of Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles. The product was manufactured by Micro Labs Limited in India for Micro Labs USA Inc. in Princeton, NJ. The specific lot number is STBG005 with an expiration date of 2/2015.
The recall was initiated because the product failed impurity content specifications, specifically regarding Butylated Hydroxy Anisole Content against shelf life specifications. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed in New York. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or replacements.
The recalled product
- Product
- Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
- Manufacturer
- Micro Labs Usa, Inc S
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,008
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 (2)
- Lot #: STBG005
- Exp 2/2015
Distribution
Distributed in 1 state:
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