Recalls / Class II

Class IID-222-2013

Product

PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09

Affected lot / code info

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

Why it was recalled

Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.

Recalling firm

Firm

Physicians Total Care, Inc.

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

12515 E 55th St Ste 100, Tulsa, Oklahoma 74146-6234

Distribution

Quantity

3660 capsules

Distribution pattern

FL, NC, TX, CO, VA, SC, GA, KS, LA, MO

Timeline

Recall initiated

2012-02-20

FDA classified

2013-03-27

Posted by FDA

2013-04-03

Terminated

2013-05-17

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-222-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.