Drug product
PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09
D-222-2013
Product summary
- Event
- Event 63891
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3660 capsules
- Official record key
drug-enforcement:D-222-2013
Official wording
Reason: Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Code information: 5YLZ EXP 04/13, 5ZCE EXP 04/13, 61TX EXP 04/13, 65YD EXP 07/13, 6COJ EXP 09/13, 4ZT6 EXP 02/12, 58HD EXP 02/12, 5G4L EXP 08/12, 5KBU EXP 10/12, 5M3W EXP 10/12, 5OHI EXP 10/12, 6JHL EXP 01/14, 6HJQ EXP 01/14
Distribution pattern: FL, NC, TX, CO, VA, SC, GA, KS, LA, MO
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance