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.

FDA recall notice · announced November 8, 2017 · Precision Dose

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

Subpotent Drug: low out of specification results.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot number: 500105, Exp 04/30/18
Quantity: 801 cases
Status: Terminated
Products in this recall event:
- 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 (ND (D-0057-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.