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, Manufactured by PharmaTech LLC, Davie FL
D-0227-2018
Product summary
- Firm
- Pharmatech LLC
- Event
- Event 77960
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0227-2018
Official wording
Reason: Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Code information: All lots remaining within expiry.
Distribution pattern: MI
Derived failure modes
-
Microbial contamination
Microbial Contamination