FDA Drug recall D-0375-2019
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), 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, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), 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-0375-2019 |
| 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, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), 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 #: F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F…a) Lot #: F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F700958, Exp. April 2019 b) Lot #: F700327, F700392, F700393, Exp. January 2019; F700546, F700547, F700664, Exp. March 2019; F700967, Exp. April 2019, F701106, F701107, F701108, F701109, Exp. May 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-0375-2019%22
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