Drug 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.
D-0057-2018
Product summary
- Event
- Event 78359
- Status
- Terminated
- Classification
- Class III
- Quantity
- 801 cases
- Official record key
drug-enforcement:D-0057-2018
Official wording
Reason: Subpotent Drug: low out of specification results.
Code information: Lot number: 500105, Exp 04/30/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent