Drug recall D-1497-2019

Class II Terminated reported Jul 31, 2019

Product

GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16.

Reason for recall

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Lots and codes

All lots remaining within expiry.

Recall details

Recalling firm
Pharma-Natural Inc., Miami Lakes, FL
Quantity
3000 bottles
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Type
Voluntary: Firm initiated
Recall initiated
June 21, 2019
Terminated
October 27, 2021

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