Drug product
PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08
D-221-2013
Product summary
- Event
- Event 63891
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1200 capsules
- Official record key
drug-enforcement:D-221-2013
Official wording
Reason: Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Code information: 69MO EXP 05/13, 69SH EXP 05/13, 5KXZ EXP 05/12, 5RE1 EXP 05/12
Distribution pattern: FL, NC, TX, CO, VA, SC, GA, KS, LA, MO
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance