Status
Terminated
Drug Enforcement D-311-2013
Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
Classification
Class II
Report Date
May 8, 2013
Termination Date
June 25, 2013
Product Information
- Product description
- "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.
- Product quantity
- 13,369 bottles (12oz), 2607 bottles (26oz)
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
- Address
-
16311 NW 52nd Ave
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-311-2013
- Event ID
- 64963
- Recall initiation date
- March 16, 2013
- Center classification date
- May 2, 2013
- Code info
- Lot Number #:13B0023; exp 02/15 FP-4809 (12oz) FP-4810 (26oz)
- More code info
- —