The Recall Desk
ModerateFDA (Drugs)·D-1506-2019·Announced 2019-07-31

Pharma-Natural Recalls NEOGEN-D Cough Syrup Due to Manufacturing Violations

Pharma-Natural Inc. is recalling 2,052 bottles of NEOGEN-D cough syrup because the product was manufactured with current good manufacturing practice violations, including a lack of process and cleaning validation.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text cites manufacturing process violations (lack of validation) without reporting specific illnesses, injuries, or deaths, which aligns with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Pharma-Natural Inc. is recalling 2,052 bottles of 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. The product was manufactured in the USA for Kramer Novis, San Juan, PR 00917, under NDC 52083-699-16. The recall includes all lots remaining within their expiry dates.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products were manufactured with a lack of process validation, cleaning validation, and stability studies, along with other current good manufacturing practice violations.

The affected product was distributed to consignees in Florida and Texas, who may have further distributed the product nationwide in the USA and Puerto Rico. Consumers should check their medicine cabinets for this specific product and stop using it if found.

The recalled product

Product
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.
Manufacturer
Pharma-Natural Inc.
Category
Drug — Cough and Cold
Hazard
Affected units
2,052

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots remaining within expiry.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 16 recalled by Pharma-Natural Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

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