FDA-Drug2019-07-31Class III
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.
Hazard
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Sold states
Product was distributed to three major distributors who may have further distributed the product nationwide.
Affected count
a) 2,256 bottles; b) 240 bottles
Manufactured in
50 Horseblock Rd, N/A, Brookhaven, NY, United States
Products
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1516-2019Don't want to check this manually?
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