The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0769-2016·Announced 2016-03-16

Atorvastatin Calcium 40 mg Recalled for Impurity Failures

Golden State Medical Supply Inc. is recalling Atorvastatin Calcium 40 mg tablets due to failed impurities and degradation 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 agency classified this as an FDA Class III recall, 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

Golden State Medical Supply Inc. is recalling 172 100-count packages of Atorvastatin Calcium 40 mg tablets. The product is manufactured by Apotex Inc. and packaged by GSMS Inc. The recall covers three specific lots: GS009075, GS009763, and GS010178, all with expiration dates in September or October 2017.

The recall was initiated because the product failed impurities and degradation specifications. The agency 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.

Consumers and healthcare providers should check their inventory for the specific NDC number 60429-325-77 and the lot numbers listed above. If the product matches these details, it should be returned to the supplier or disposed of according to local regulations.

The recalled product

Product
Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77
Manufacturer
Golden State Medical Supply Inc.
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 (4)

  • Lot #GS009075
  • Exp. 09/17 Lot #GS009763
  • Exp. 09/17 Lot #GS010178
  • Exp. 10/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Golden State Medical Supply Inc. 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 4 products in this recall →

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