FDAClass IIIJuly 31, 2019

Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count recall

Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)

Why was Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count recalled?

Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Recalling firm
Amneal Pharmaceuticals, Inc.
Quantity
a) 2,256 bottles; b) 240 bottles
Distribution
Product was distributed to three major distributors who may have further distributed the product nationwide.
Recall date
July 31, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls