D-1523-2016 Class II Terminated
FDA drug recall D-1523-2016 was initiated by Pharmatech LLC on Aug 8, 2016 and is designated Class II. Reason for recall: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. The recall status is terminated (terminated Sep 23, 2024). Affected quantity: 12,308 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 5, 2016
- Initiation Date
- Aug 8, 2016
- Termination Date
- Sep 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,308 bottles
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 23261501, Exp 10/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1523-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026