Recalls / Class II
Class IID-1037-2017
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.
- Affected lot / code info
- Lot #: 500326, Exp. 6/30/2018
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.
Recalling firm
- Firm
- Precision Dose Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 722 Progressive Ln, N/A, South Beloit, Illinois 61080-2616
Distribution
- Quantity
- 480 (5mL) unit dose cups
- Distribution pattern
- OH and CT
Timeline
- Recall initiated
- 2017-07-05
- FDA classified
- 2017-07-31
- Posted by FDA
- 2017-08-09
- Terminated
- 2018-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1037-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.