Drug product
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76006, NDC 58657-500-16
D-0210-2018
Product summary
- Event
- Event 78757
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,707 bottles
- Official record key
drug-enforcement:D-0210-2018
Official wording
Reason: Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Code information: Lot: 08616; Exp. 07/18
Distribution pattern: Texas
Derived failure modes
-
Microbial contamination
Microbial Contamination