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.
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
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