The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0905-2017·Announced 2017-06-21

Safecor Health Recalls Metronidazole Tablets Due to CGMP Deviations

Safecor Health LLC is voluntarily recalling 1,933 bottles of Metronidazole 500mg tablets 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 due to CGMP deviations, which typically indicates a remote probability of serious adverse health consequences, aligning with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Safecor Health LLC is voluntarily recalling 1,933 bottles of Metronidazole 500mg tablets, 50-count bottles, prescription only. The affected product is identified by Lot # A25593 with an expiration date of 02/22/2017. The recall was initiated by the firm on July 7, 2016, and was classified as Class II by the FDA.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The product was distributed in Massachusetts and New York. The FDA classified this recall as Class II, which indicates 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.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall was terminated on July 12, 2017.

The recalled product

Product
Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402
Manufacturer
Safecor Health, LLC
Category
Drug — Antibiotic
Hazard
Affected units
1,933

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 # A25593
  • Exp. 02/22/2017

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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