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Class II: temporary or reversible health riskTerminated

Woodfield Pharmaceutical Codeine-Guaifenesin Oral Solution 10-100 Recall

Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl

Woodfield Pharmaceutical, LLC · Houston, TX

Risk level
Class II
Reported by FDA
Jan 17, 2018
Recall ID
D-0210-2018
Check your lot numberHow we source this data

Summary

Woodfield Pharmaceutical recalled Codeine-Guaifenesin Oral Solution 10-100 starting Dec 12, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0210-2018 on Jan 17, 2018. Reason: Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia. Status: Terminated.

Why it was recalled

Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia

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

Lot numbers, UPCs & expiration codes

Lot: 08616; Exp. 07/18

Where it was sold

Texas

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0210-2018
Classification
Class II
Status
Terminated
Recall initiated
Dec 12, 2017
FDA report date
Jan 17, 2018
Quantity
15,707 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Woodfield Pharmaceutical, LLC

Original FDA data

Every field from FDA enforcement report D-0210-2018, exactly as published.

Show all FDA fields
City
Houston
State
TX
Status
Terminated
Country
United States
Event ID
78757
Address
10863 Rockley Rd
Code information
Lot: 08616; Exp. 07/18
Postal code
77099-3405
Report date
Jan 17, 2018
Product type
Drugs
Recall number
D-0210-2018
Classification
Class II
Recalling firm
Woodfield Pharmaceutical, LLC
Product quantity
15,707 bottles
Termination date
Jan 24, 2020
Reason for recall
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Texas
Recall initiation date
Dec 12, 2017
Initial firm notification
Letter
Center classification date
Jan 8, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0210-2018, published Jan 17, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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