FDA Drug recall D-0108-2018
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By:…
- FDA Drug
- Class III
- terminated
- Published 2017-12-20
On 2017-12-20 the FDA classified a Class III recall of Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By:… by Teva Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0108-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-11-28 |
| Published | 2017-12-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.
Reason
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Identifiers
| ndc | 0093-1172-01 |
|---|---|
| ndc | 0093-1172-10 |
| ndc | 0093-1174-01 |
| ndc | 0093-1174-10 |
| ndc | 0093-4125-73 |
| ndc | 0093-4125-74 |
| ndc | 0093-4127-73 |
| ndc | 0093-4127-74 |
| code_info | Lot # 35433115A, Exp 01/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All Teva Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0108-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.