Why it was recalled
Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
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.
Lot numbers, UPCs & expiration codes
Lot Number #:13B0023; exp 02/15 FP-4809 (12oz) FP-4810 (26oz)
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-311-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 16, 2013
- FDA report date
- May 8, 2013
- Quantity
- 13,369 bottles (12oz), 2607 bottles (26oz)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-311-2013, exactly as published.
Show all FDA fields
- City
- Miami Gardens
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 64963
- Address
- 16311 NW 52nd Ave
- Code information
- Lot Number #:13B0023; exp 02/15 FP-4809 (12oz) FP-4810 (26oz)
- Postal code
- 33014-6209
- Report date
- May 8, 2013
- Product type
- Drugs
- Recall number
- D-311-2013
- Classification
- Class II
- Recalling firm
- Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
- Product quantity
- 13,369 bottles (12oz), 2607 bottles (26oz)
- Termination date
- Jun 25, 2013
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 16, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 2, 2013