Reported Jul 31, 2019 · Terminated
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Amneal Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amneal Pharmaceuticals, Inc. · 50 Horseblock Rd · Brookhaven, NY · 11719-9509
Is this the product you have?
- Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
- Lot codes and dates
a) Lot # BA10619Ab) Lot # BA10619Bexp. date 07/2020
- Amount recalled
- a) 2,256 bottles; b) 240 bottles
Where it was sold
- Nationwide
Why it was recalled
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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