RecallDepth
Class III Terminated

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.

This recall has been terminated (originally issued November 8, 2017).

Company
Precision Dose Inc.
Recall Initiated
September 25, 2017
Posted
November 8, 2017
Recall Number
D-0057-2018
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
801 cases
Firm Location
South Beloit, IL, United States
Official Source
View on FDA website ↗

Reason for Recall

Subpotent Drug: low out of specification results.

Distribution

Nationwide in the USA

Lot / Code Info

Lot number: 500105, Exp 04/30/18

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