The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0409-2015·Announced 2015-03-18

Micro Labs Recalls Simvastatin Tablets Due to Impurity Failure

Micro Labs USA Inc. is recalling 13,464 bottles of Simvastatin 80mg tablets 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a failed impurity specification without reported illness, fitting the criteria for a moderate or low-risk precautionary recall.

Plain-English summary

Micro Labs USA Inc. is recalling 13,464 bottles of Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles. The product was manufactured by Micro Labs Limited in India for Micro Labs USA Inc. in Princeton, NJ. The recall covers two specific lots: Lot STEG004 with an expiration date of 2/2015 and Lot STEG006 with an expiration date of 3/2015.

The recall was initiated because the product failed a known impurity specification. The affected bottles were distributed nationwide.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
Manufacturer
Micro Labs Usa, Inc S
Category
Drug — Prescription Medication
Hazard
Affected units
13,464

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 (3)

  • Lot #: STEG004
  • Exp 2/2015
  • Lot #: STEG006 Exp 3/2015

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 →

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