The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1516-2019·Announced 2019-07-31

Amneal Recalls Methylergonovine Maleate Tablets Due to Foreign Tablet Presence

Amneal Pharmaceuticals is recalling specific lots of Methylergonovine Maleate tablets because a Promethazine tablet was found in a bottle.

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 FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a foreign object (wrong tablet) rather than a high-risk pathogen or structural defect, fitting the Moderate category for minor labeling or contamination issues without reported serious injury.

Plain-English summary

Amneal Pharmaceuticals, Inc. is recalling Methylergonovine Maleate USP 0.2 mg Tablets in 12-count and 28-count bottles. The recall involves Lot # BA10619A (12-count) and Lot # BA10619B (28-count), both with an expiration date of 07/2020. The total quantity affected is 2,256 bottles of the 12-count version and 240 bottles of the 28-count version.

The recall was initiated due to the presence of a foreign tablet; specifically, one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets. The product was distributed to three major distributors, who may have further distributed the product nationwide.

Consumers should check their medication for the specific lot numbers and expiration dates listed above. If they possess the affected product, they should stop using it and contact their healthcare provider or the recalling firm for instructions on return or replacement.

The recalled product

Product
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Manufacturer
Amneal Pharmaceuticals, Inc.
Category
Drug — Tablets
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 (3)

  • a) Lot # BA10619A
  • b) Lot # BA10619B
  • exp. date 07/2020

Distribution

Distributed nationwide across the United States.

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