Why it was recalled
Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
Product description
TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02
Lot numbers, UPCs & expiration codes
Lot 3C11 and 3C11A
Where it was sold
U.S. 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-850-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 18, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 300,480 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline, LLC.
Original FDA data
Every field from FDA enforcement report D-850-2013, exactly as published.
Show all FDA fields
- City
- Zebulon
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 65856
- Address
- 1011 North Arendell Ave
- Code information
- Lot 3C11 and 3C11A
- Postal code
- 27597-1217
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-850-2013
- Classification
- Class III
- Recalling firm
- GlaxoSmithKline, LLC.
- Product quantity
- 300,480 bottles
- Termination date
- May 18, 2016
- Reason for recall
- Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Jul 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 7, 2013