Lupin Pharmaceuticals Inc. is recalling a half million bottles of cefdinir for oral suspension, according to the January 16, 2019, US Food and Drug Administration (FDA) Enforcement Report. The firm initiated the voluntary recall after reports that the reconstituted suspension was especially thick.
The recall affects the following products, which were distributed throughout the United States:
- cefdinir for oral suspension USP, 125 mg/5 mL, 60 mL (NDC 68180-722-20), from lots F700329, F700330, and F700328 (Exp. 1/19), F700544, F700545, F700668, F700669, and F700670 (Exp. 3/19), and F700958 (Exp. 4/19);
- cefdinir for oral suspension USP, 125 mg/5 mL, 100 mL (NDC 68180-722-10), from lots F700327, F700392, and F700393 (Exp. 1/19), F700546, F700547, and F700664 (Exp. 3/19), F700967 (Exp. 4/19), and F701106, F701107, F701108, and F701109 (Exp. 5/19);
- cefdinir for oral suspension USP, 250 mg/5 mL, 60 mL (NDC 68180-723-20), from lots F700343, F700344, F700345, F700346, F700347, F700376, F700377, F700415, F700146, F700417, and F700418 (Exp. 1/19), F700419, F700420, F700492, F700493, F700508, and F700665 (Exp. 2/19), and F700784 (Exp. 4/19); and
- cefdinir for oral suspension USP, 250 mg/5 mL, 100 mL (NDC 68180-723-10), from lots F700324, F700325, and F700326 (Exp. 1/19), and F700618, F700619, and F700620 (Exp. 2/19).
Lupin Pharmaceuticals initiated the recall January 2, 2019. On January 15, 2019, the FDA designated it Class II. The classification suggests use of the product could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.
Cefdinir for oral suspension is a prescription antibiotic used to treat a range of bacterial infections.
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