Drug 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
D-1122-2017
Product summary
- Event
- Event 77869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,715 bottles
- Official record key
drug-enforcement:D-1122-2017
Official wording
Reason: Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Code information: Item # 370339, all lots
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial contamination