Class II · Moderate risk
Carbamazepine Tablets
CGMP deviations: tablets with black specks.
Carbamazepine Oral Suspension USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: low out of specification results.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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.
Affected NDCs
68094-0301-59
68094-0301-62
Compare with the code on your package — it is the most precise check available.
Drug: Carbamazepine
- Recalling firm
- Precision Dose Inc.
- NDC code
- 68094-301-59
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0057-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Carbamazepine recalls
See all
Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Carbamazepine Extended-Release Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Carbamazepine Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Carbamazepine 200mg Tablets
Failed Dissolution Specifications
Other recalls by Precision Dose Inc.
All 2017 recalls
Class II · Moderate risk
Glycopyrrolate Oral Solution
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Acetaminophen Oral Suspension
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class II · Moderate risk
Acetaminophen Oral Suspension
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class II · Moderate risk
Chlorhexidine Gluconate Oral Rinse USP 0.12%
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
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