Aller-Chlor — Class II drug recall D-1523-2016
Terminated recall by Pharmatech LLC, reported 2016-10-05, distributed nationwide. CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination
| Recall number | D-1523-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmatech LLC, Davie, FL, United States |
| Recall initiated | 2016-08-08 |
| Classified | 2016-09-27 |
| Reported by FDA | 2016-10-05 |
| Terminated | 2024-09-23 |
| Distributed | Nationwide (US) |
| Quantity | 12,308 bottles |
| Reason classes | microbial contamination, cgmp |
| Pathogens | burkholderia |
| NDC | 00536-1025-47 |
| Lot numbers | 10/17, 23261501 |
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.
Reason for recall
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
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-1523-2016. 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.