The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1498-2019·Announced 2019-07-31

Pharma-Natural Recalls Double Tussin DM Due to Manufacturing Violations

Pharma-Natural Inc. is recalling 500 bottles of Double Tussin DM because the product was manufactured with current good manufacturing practice violations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4).

Plain-English summary

Pharma-Natural Inc. is recalling 500 bottles of Double Tussin DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in 4 FL OZ (120 mL) bottles. The product is distributed by Pamby Dist. in Miami, FL, and carries NDC 63708-121-04. 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, stability studies, and other CGMP violations. The agency has classified this recall as Class II.

The 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 home medicine cabinets for this specific product and stop using it if found.

The recalled product

Product
DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
Manufacturer
Pharma-Natural Inc.
Category
Drug — Cough and Cold
Hazard
Affected units
500

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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