Class II · Moderate risk Ongoing
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by…
Reason Subpotent Drug
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
What was recalled
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.
- NDC code
- 69238-1605-02
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1516-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by…
Reason Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing…
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Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
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Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton…
Reason Lack of Assurance of Sterility
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