Drug Enforcement D-222-2013

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

Status

Terminated

Classification

Class II

Report Date

April 3, 2013

Termination Date

May 17, 2013

Product Information

Product description
PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09
Product quantity
3660 capsules
Reason for recall
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Recall initiation reason
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
FL, NC, TX, CO, VA, SC, GA, KS, LA, MO

Location & Firm

Recalling firm
Physicians Total Care, Inc.
Address
12515 E 55th St Ste 100

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-222-2013
Event ID
63891
Recall initiation date
February 20, 2012
Center classification date
March 27, 2013
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
More code info