FDAFDA · Food and drugs·Recall number D-1523-2016
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.
Published October 5, 2016 · Recall initiated: August 8, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pharmatech LLC
- Distributor
- Nationwide
- Lot
- Lot #: 23261501, Exp 10/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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