Recalls / Class III
Class IIID-0057-2018
Product
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 lot / code info
- Lot number: 500105, Exp 04/30/18
Why it was recalled
Subpotent Drug: low out of specification results.
Recalling firm
- Firm
- Precision Dose Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 722 Progressive Ln, N/A, South Beloit, Illinois 61080-2616
Distribution
- Quantity
- 801 cases
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-09-25
- FDA classified
- 2017-11-01
- Posted by FDA
- 2017-11-08
- Terminated
- 2018-04-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0057-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.