The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1122-2017·Announced 2017-08-30

Rugby Aller-chlor Syrup Recalled for Microbial Contamination

The Harvard Drug Group is recalling 4,715 bottles of 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 FDA classified this recall as Class II, which corresponds to a 'Severe' rating under the rubric, as it involves a risk of temporary or medically reversible adverse health consequences.

Plain-English summary

The Harvard Drug Group is recalling 4,715 bottles of Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles. The product is distributed by Rugby Laboratories and is identified by Item # 370339, all lots. The recall was initiated because of microbial contamination, specifically the presence of yeast and potential B. cepacia contamination.

The recalled product was distributed nationwide in the USA. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.

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
Manufacturer
The Harvard Drug Group
Category
Drug — Syrup
Hazard
Affected units
4,715

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)

  • Item # 370339
  • all lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by The Harvard Drug Group 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 5 products in this recall →

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