The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0901-2017·Announced 2017-06-21

Safecor Health Recalls Atorvastatin Calcium 40mg Tablets Due to CGMP Deviations

Safecor Health is voluntarily recalling 119 bottles of Atorvastatin Calcium 40mg tablets in Massachusetts and New York due to Current Good Manufacturing Practice (CGMP) deviations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 recall is classified as FDA Class II and is a voluntary, firm-initiated action due to CGMP deviations without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Safecor Health, LLC is voluntarily recalling 119 bottles of Atorvastatin Calcium 40mg tablets, 30-count bottles, prescription only. The product is identified by NDC 60505258009, Lot # A18661, and an expiration date of 10/31/2017.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed in Massachusetts and New York. The recall was initiated on July 7, 2016, and was terminated on July 12, 2017.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall was initiated by the firm and classified as Class II by the FDA.

The recalled product

Product
Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009
Manufacturer
Safecor Health, LLC
Category
Drug — Prescription Medication
Hazard
Affected units
119

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 # A18661
  • Exp. 10/31/2017

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 6 recalled by Safecor Health, LLC 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 6 products in this recall →

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