FDA Drug recall D-0012-2021
Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-…
- FDA Drug
- Class II
- terminated
- Published 2020-09-16
On 2020-09-16 the FDA classified a Class II recall of Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-… by Teva Pharmaceuticals Usa, citing CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0012-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-24 |
| Published | 2020-09-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Reason
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Identifiers
| ndc | 0093-3145-01 |
|---|---|
| ndc | 0093-3145-05 |
| ndc | 0093-3147-01 |
| ndc | 0093-3147-05 |
| ndc | 0093-4175-73 |
| ndc | 0093-4175-74 |
| ndc | 0093-4177-73 |
| ndc | 0093-4177-74 |
| code_info | Lot #s: a) 30309820A, Exp. 08/2020; 30310000B, 30310001B, Exp. 10/2020; 30310096A Exp. 01/2021; 30310228A, Exp. 03/2021…Lot #s: a) 30309820A, Exp. 08/2020; 30310000B, 30310001B, Exp. 10/2020; 30310096A Exp. 01/2021; 30310228A, Exp. 03/2021; 30310313A, Exp. 06/2021; b) 30309861A, Exp. 08/2020; 30310335A, Exp. 06/2021. |
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-0012-2021%22
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