Class II · Moderate risk
Carbamazepine Tablets
CGMP deviations: tablets with black specks.
Carbamazepine Oral Suspension
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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.
Affected NDC
68094-0301-59
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-1037-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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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