PlainRecalls
FDA Drug Moderate Class II Terminated

NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.

Reported: July 31, 2019 Initiated: June 21, 2019 #D-1506-2019

Product Description

NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.

Reason for Recall

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

Details

Recalling Firm
Pharma-Natural Inc.
Units Affected
2052 bottles
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Location
Miami Lakes, FL

Frequently Asked Questions

What product was recalled?
NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.. Recalled by Pharma-Natural Inc.. Units affected: 2052 bottles.
Why was this product recalled?
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 31, 2019. Severity: Moderate. Recall number: D-1506-2019.