Axara Recalls Well at Walgreens Antacid Liquid Due to E. Coli Contamination
Tarmac Products, Inc. is recalling specific lots of Well at Walgreens Regular Strength Antacid Liquid due to elevated microbial counts and E. Coli contamination.
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 involves E. Coli contamination, which is a high-risk pathogen. Per the rubric, high-risk pathogens without reported illness are typically High (3), but the presence of a specific pathogen like E. Coli in a drug product often warrants Severe (4) due to the potential for significant injury, aligning with the 'significant injury/property-damage reports' or high-risk pathogen criteria when combined with the FDA Class II classification.
Plain-English summary
Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals is recalling specific lots of "Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint. The recall involves 12 oz bottles (NDC 0363-0073-02) and 26 oz bottles (NDC 0363-0073-26) distributed by Walgreens CO. The affected lot number is 13B0023 with an expiration date of 02/15. The recall covers 13,369 bottles of the 12 oz size and 2,607 bottles of the 26 oz size, which were distributed nationwide.
The recall was initiated because the lot in question had an elevated microbial count outside of specifications and was found to have E. Coli contamination. This is a non-sterile product recall involving microbial contamination.
Consumers should check their inventory for the specific lot number 13B0023 and expiration date 02/15. If they possess these products, they should stop using them and contact the recalling firm or their point of purchase for instructions on return or disposal.
The recalled product
- Product
- "Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015.
- Category
- Drug — Antacid
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 Number #:13B0023
- exp 02/15 FP-4809 (12oz) FP-4810 (26oz)
Distribution
Distributed nationwide across the United States.
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