FDA Drug recall D-1037-2017
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-30…
- FDA Drug
- Class II
- terminated
- Published 2017-08-09
On 2017-08-09 the FDA classified a Class II recall of Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-30… by Precision Dose, citing labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1037-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-05 |
| Published | 2017-08-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Precision Dose |
| Distribution | CT, OH |
Product
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
Reason
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Identifiers
| code_info | Lot #: 500326, Exp. 6/30/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Precision Dose
- Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, ND…
FDA Drug · Class II · 2026-07-29 · Precision Dose - Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 3…
FDA Drug · Class II · 2021-11-17 · Precision Dose - Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count…
FDA Drug · Class II · 2021-11-17 · Precision Dose - Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit…
FDA Drug · Class II · 2021-01-20 · Precision Dose - Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62
FDA Drug · Class II · 2020-03-18 · Precision Dose
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1037-2017%22
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