Drug Enforcement D-221-2013

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, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08
Product quantity
1200 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-221-2013
Event ID
63891
Recall initiation date
February 20, 2012
Center classification date
March 27, 2013
Code info
69MO EXP 05/13, 69SH EXP 05/13, 5KXZ EXP 05/12, 5RE1 EXP 05/12
More code info