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.
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 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
- Category
- Drug — Syrup
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.
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