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Recall Observatory FDA recall evidence

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

February 20, 2012

Class II

Product summary

Firm
Physicians Total Care, Inc.
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

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance