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.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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:
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