D-0210-2018 Class II Terminated
FDA drug recall D-0210-2018 was initiated by Woodfield Pharmaceutical, LLC on December 12, 2017 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia The recall status is terminated (terminated January 24, 2020). Affected quantity: 15,707 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 17, 2018
- Initiation Date
- December 12, 2017
- Termination Date
- January 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,707 bottles
Product Description
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
Reason for Recall
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Distribution Pattern
Texas
Code Information
Lot: 08616; Exp. 07/18