Rugby Aller-chlor — Class II drug recall D-1122-2017
Terminated recall by The Harvard Drug Group, reported 2017-08-30, distributed nationwide. Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
| Recall number | D-1122-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2017-08-02 |
| Classified | 2017-08-24 |
| Reported by FDA | 2017-08-30 |
| Terminated | 2024-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 4,715 bottles |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia, yeast |
| NDC | 00536-1025-47 |
| Model numbers | 370339 |
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
Reason for recall
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1122-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.