December 2017 FDA Recall Codeine-guaifenesin by Woodfield Pharmaceutical, Llc
D-0210-2018 - Microbial Contamination of Non-Sterile Products
This Class II drug recall was voluntarily initiated by Woodfield Pharmaceutical, Llc on December 12, 2017 for the product Codeine-guaifenesin. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed in Texas and the recall is currently terminated.
Recall Number: D-0210-2018
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
12-12-2017
01-17-2018
15,707 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Woodfield Pharmaceutical, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Texas
01-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot: 08616; Exp. 07/18
