The Recall Desk
ModerateFDA (Drugs)·D-1521-2016·Announced 2016-10-05

Pharmatech Recalls Ninjacof Cough Syrup Due to B. cepacia Contamination Risk

Pharmatech LLC is recalling Ninjacof cough syrup due to a potential risk of contamination with B. cepacia bacteria.

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 is described as a precautionary measure due to a potential risk of contamination, which aligns with the rubric for voluntary precautionary recalls.

Plain-English summary

Pharmatech LLC is recalling 5,928 bottles of Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid. The product is a 16 fl oz (473 mL) bottle containing 12.5 mg/12.5 mg in each 5 mL, manufactured for Centurion Labs, LLC. The specific lot number is 25291601 with an expiration date of 03/18.

The recall was initiated as a precautionary measure due to Current Good Manufacturing Practice (CGMP) deviations that created a potential risk of product contamination with the bacteria B. cepacia. The product was distributed nationwide.

Consumers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance. The recall is classified as FDA Class II.

The recalled product

Product
NINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE)
Brand
NINJACOF
Manufacturer
Pharmatech LLC
Affected units
5,928

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 (2)

  • Lot #: 25291601
  • Exp 03/18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Pharmatech LLC 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 7 products in this recall →