CLASS II Drug recall · Reported 9 Aug 2017 · FDA Enforcement Report
Carbamazepine Oral Suspension recalled by Precision Dose
Precision Dose is recalling Carbamazepine Oral Suspension, USP, distributed in Connecticut, Ohio. The recall was initiated on 5 Jul 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1037-2017
- FDA event ID
- 77732
- Recalling firm
- Precision Dose, South Beloit, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jul 2017
- FDA classified
- 31 Jul 2017
- Reported
- 9 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Drug class
- Seizure Medication
Timeline
| 5 Jul 2017 | Recall initiated by company | |
| 31 Jul 2017 | Classified by FDA | +26 days |
| 9 Aug 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Product as listed by the FDA
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.
Where it was distributed
OH and CT
Questions about this recall
Why was it recalled?
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Which lots are affected?
Lot #: 500326, Exp. 6/30/2018
Where was it sold?
OH and CT
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Precision Dose
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glycopyrrolate Oral Solution, 1 mg/, delivers recalled by Precision DoseGlycopyrrolate | Precision Dose | Potency & Assay | Nationwide |
| Drug | CLASS II | Acetaminophen Oral Suspension, 160 mg recalled by Precision DoseAcetaminophen | Precision Dose | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen Oral Suspension, 325 mg recalled by Precision DoseAcetaminophen | Precision Dose | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Chlorhexidine Gluconate Oral Rinse recalled by Precision Dose | Precision Dose | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ranitidine Oral Solution, USP, 150 mg/, [ x Dose Cups recalled | Precision Dose | Nitrosamine Impurity | Nationwide |
Other Carbamazepine recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbamazepine Extended-Release Tablets recalledCarbamazepine | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP 200 mg recalled by Torrent PharmaCarbamazepine | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine 200mg Tablets, USP, 200 mg Unit Dose recalled | The Harvard Drug Group | Potency & Assay | NC |