The Recall Desk
ModerateFDA (Drugs)·D-1505-2019·Announced 2019-07-31

Pharma-Natural Recalls SORBUGEN Cough Syrup Due to Manufacturing Violations

Pharma-Natural Inc. is recalling 7,392 bottles of SORBUGEN cough syrup because the product was manufactured with current good manufacturing practice violations.

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, but the source text does not report any illnesses, injuries, or specific contamination hazards, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Pharma-Natural Inc. is recalling 7,392 bottles of SORBUGEN (Dextromethorphan Hydrobromide, Glyceryl Guaiacolate) grape flavor cough syrup. The product is available in 16 Fl.oz. (473 mL) bottles and is manufactured in the USA for Kramer Novis. The recall covers 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 CGMP violations.

The affected product was distributed to consignees in Florida and Texas, who may have further distributed it 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
SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE)
Brand
SORBUGEN
Manufacturer
Pharma-Natural Inc.
Category
Drug — OTC Cough Syrup
Hazard
Affected units
7,392

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.

UPCs (1)

  • 0352083660160

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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