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Recall Observatory FDA recall evidence

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

February 20, 2012

Class II

Product summary

Firm
Physicians Total Care, Inc.
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

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance