Recalls / Class III
Class IIID-850-2013
Product
TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02
- Brand name
- Tums
- Generic name
- Calcium Carbonate
- Active ingredient
- Calcium Carbonate
- Route
- Oral
- NDCs
- 0135-0118, 0135-0180, 0135-0181, 0135-0228, 0135-0540
- FDA application
- M001
- Affected lot / code info
- Lot 3C11 and 3C11A
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
Recalling firm
- Firm
- GlaxoSmithKline, LLC.
- Manufacturer
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1011 North Arendell Ave, N/A, Zebulon, North Carolina 27597-1217
Distribution
- Quantity
- 300,480 bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2013-07-18
- FDA classified
- 2013-08-07
- Posted by FDA
- 2013-08-14
- Terminated
- 2016-05-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-850-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.