Drug product
TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02
D-850-2013
Product summary
- Event
- Event 65856
- Status
- Terminated
- Classification
- Class III
- Quantity
- 300,480 bottles
- Official record key
drug-enforcement:D-850-2013
Official wording
Reason: Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
Code information: Lot 3C11 and 3C11A
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets