Recalls / Class II
Class IID-1523-2016
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.
- Affected lot / code info
- Lot #: 23261501, Exp 10/17
Why it was recalled
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Recalling firm
- Firm
- Pharmatech LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4131 Sw 47th Ave, Suite 1403, Davie, Florida 33314-4026
Distribution
- Quantity
- 12,308 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-08-08
- FDA classified
- 2016-09-27
- Posted by FDA
- 2016-10-05
- Terminated
- 2024-09-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1523-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.