The Recall Desk
SevereFDA (Drugs)·D-0227-2018·Announced 2018-01-24

Rugby Aller-chlor Syrup Recalled for Microbial Contamination

Pharmatech LLC is recalling Rugby Aller-chlor syrup due to microbial contamination, including yeast and potential B. cepacia.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or specific high-risk contexts map to Severe (4). While no specific injuries are listed, the presence of B. cepacia in a non-sterile product is a significant hazard.

Plain-English summary

Pharmatech LLC is recalling Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles. The product is distributed by Rugby Laboratories and manufactured by Pharmatech LLC. The recall covers all lots remaining within their expiry dates.

The recall was initiated due to microbial contamination of the non-sterile product. The source text identifies the presence of yeast and potential B. cepacia contamination. The agency has classified this as a Class II recall.

The distribution pattern is listed as Michigan (MI). Consumers should check their inventory for this specific product and NDC number (0536-1025-47). If found, they should stop using the product and contact the recalling firm or their healthcare provider for instructions.

The recalled product

Product
Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL
Manufacturer
Pharmatech LLC

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 in 1 state:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →