FDA Drug recall D-0057-2018
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per cas…
- FDA Drug
- Class III
- terminated
- Published 2017-11-08
On 2017-11-08 the FDA classified a Class III recall of Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per cas… by Precision Dose, citing subpotent Drug: low out of specification results.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0057-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-09-25 |
| Published | 2017-11-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Precision Dose |
| Distribution | US |
Product
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
Reason
Subpotent Drug: low out of specification results.
Identifiers
| code_info | Lot number: 500105, Exp 04/30/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0057-2018%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.