The Recall Desk
ModerateFDA (Drugs)·D-1523-2016·Announced 2016-10-05

Pharmatech Recalls Aller-Chlor Syrup Due to Potential B. cepacia Contamination

Pharmatech LLC is recalling 12,308 bottles of Aller-Chlor Syrup nationwide 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 and low-risk contamination without reported illness.

Plain-English summary

Pharmatech LLC is recalling 12,308 bottles of Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottles. The product is distributed by Rugby Laboratories and carries the NDC 0536-1025-47. The specific lot number is 23261501, with an expiration date of 10/17.

The recall was initiated as a precautionary measure due to Current Good Manufacturing Practice (CGMP) deviations. There is a potential risk that the product may be contaminated with the bacteria B. cepacia. The affected product was distributed nationwide.

Consumers who have this product should stop using it and contact their pharmacist or the recalling firm for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1025-47.
Manufacturer
Pharmatech LLC
Affected units
12,308

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 #: 23261501
  • Exp 10/17

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 →