FDA Drug recall D-0376-2019
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for:…
- FDA Drug
- Class II
- terminated
- Published 2019-01-16
On 2019-01-16 the FDA classified a Class II recall of Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for:… by Lupin Pharmaceuticals, citing CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0376-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-02 |
| Published | 2019-01-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Reason
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Identifiers
| ndc | 68180-722-20 |
|---|---|
| ndc | 68180-722-10 |
| ndc | 68180-722-04 |
| ndc | 68180-722-05 |
| ndc | 68180-723-20 |
| ndc | 68180-723-10 |
| ndc | 68180-723-04 |
| ndc | 68180-723-05 |
| code_info | a) Lot #: F700343, F700344, F700345, F700346, F700347,F700376, F700377, F700415, F700146,F700417, F700418, Exp. Jan 201…a) Lot #: F700343, F700344, F700345, F700346, F700347,F700376, F700377, F700415, F700146,F700417, F700418, Exp. Jan 2019; F700419, F700420, F700492, F700493,F700508,F700665, Exp. February 2019; F700784, Exp. April 2019; b) Lot #: F700324, F700325, F700326, Exp. January 2019; F700618, F700619, F700620, Exp. February 2019. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0376-2019%22
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