Recalls / Class II
Class IID-0210-2018
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
- Brand name
- Codeine-guaifenesin
- Generic name
- Codeine Phosphate And Guaifenesin
- Active ingredients
- Codeine Phosphate, Guaifenesin
- Route
- Oral
- NDC
- 58657-500
- FDA application
- M012
- Affected lot / code info
- Lot: 08616; Exp. 07/18
Why it was recalled
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Recalling firm
- Firm
- Woodfield Pharmaceutical, LLC
- Manufacturer
- Method Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10863 Rockley Rd, N/A, Houston, Texas 77099-3405
Distribution
- Quantity
- 15,707 bottles
- Distribution pattern
- Texas
Timeline
- Recall initiated
- 2017-12-12
- FDA classified
- 2018-01-08
- Posted by FDA
- 2018-01-17
- Terminated
- 2020-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0210-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.