The Recall Desk
SevereFDA (Drugs)·D-0210-2018·Announced 2018-01-17

Woodfield Recalls Codeine-Guaifenesin Oral Solution Due to Potential Bacterial Contamination

Woodfield Pharmaceutical is recalling 15,707 bottles of Codeine-Guaifenesin Oral Solution in Texas due to potential contamination with Burkholderia cepacia bacteria.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves potential contamination with Burkholderia cepacia, a pathogen that can cause serious infections, meeting the criteria for a Severe rating.

Plain-English summary

Woodfield Pharmaceutical, LLC is recalling 15,707 bottles of Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL. The product is an antitussive expectorant manufactured for Method Pharmaceuticals, LLC, and is identified by NDC 58657-500-16. The specific lot affected is 08616 with an expiration date of 07/18.

The recall was initiated due to a potential microbial contamination with the bacteria Burkholderia cepacia. This is a non-sterile product recall. The affected units were distributed in Texas.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN)
Brand
CODEINE-GUAIFENESIN
Manufacturer
Woodfield Pharmaceutical, LLC
Category
Drug — Oral Solution
Hazard
Affected units
15,707

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 08616
  • Exp. 07/18

Distribution

Distributed in 1 state:

Related recalls

Same hazard · bacterial contamination

See all →