FDA Recalls Atorvastatin Calcium 80 mg Due to Impurity Failures
Golden State Medical Supply Inc. is recalling specific lots of Atorvastatin Calcium 80 mg tablets because they failed impurity and degradation specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Golden State Medical Supply Inc. is recalling 168 100-count packages of Atorvastatin Calcium 80 mg tablets. The product is manufactured by Apotex Inc. and packaged by GSMS Inc. The recall covers five specific lot numbers: GS005603, GS006691, GS009073, GS009395, and GS009764, with expiration dates ranging from October 2015 to October 2017.
The recall was initiated because the product failed impurities and degradation specifications. This is classified as an FDA Class III recall, which indicates that the violation is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Atorvastatin Calcium 80 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 # 60429-326-77
- 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 (6)
- Lot #GS005603
- Exp. 10/15 Lot #GS006691
- Exp. 08/17 Lot #GS009073
- Exp. 08/17 Lot #GS009395
- Exp. 08/17 Lot #GS009764
- 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.
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