Why it was recalled
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
Product description
Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0073-02, UPC 3 11917 15114 4.
Lot numbers, UPCs & expiration codes
Lot #: 7599 (Refer to lot 13L0009), 7600 (Refer to lot 13K0014), 7622 (Refer to lot 13L0008), 7623 (Refer to lot 13K0015), Exp 10/15
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-0419-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 6, 2015
- FDA report date
- Mar 25, 2015
- Quantity
- 78,591 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tarmac Products, Inc.
Original FDA data
Every field from FDA enforcement report D-0419-2015, exactly as published.
Show all FDA fields
- City
- Miami Gardens
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 70577
- Address
- 16311 NW 52nd Ave
- Code information
- Lot #: 7599 (Refer to lot 13L0009), 7600 (Refer to lot 13K0014), 7622 (Refer to lot 13L0008), 7623 (Refer to lot 13K0015), Exp 10/15
- Postal code
- 33014-6209
- Report date
- Mar 25, 2015
- Product type
- Drugs
- Recall number
- D-0419-2015
- Classification
- Class II
- Recalling firm
- Tarmac Products, Inc.
- Product quantity
- 78,591 bottles
- Termination date
- Dec 30, 2016
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0073-02, UPC 3 11917 15114 4.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 6, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 18, 2015