Multi-event February 2012 FDA Recall Drug by Physicians Total Care, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Physicians Total Care, Inc. on February 20, 2012 for the product Drug. The FDA reported the reason for recall as presence of foreign substance(s). The product was distributed in FL, NC, TX, CO, VA, SC, GA, KS, LA, MO and the recall is currently terminated.
Reported Recall Events
Recall Number: D-222-2013
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
02-20-2012
04-03-2013
3660 capsules
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Physicians Total Care, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
FL, NC, TX, CO, VA, SC, GA, KS, LA, MO
05-17-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09
Batch or Lot Expiration Information
Lot# 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
Recall Number: D-221-2013
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
02-20-2012
04-03-2013
1200 capsules
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Physicians Total Care, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
FL, NC, TX, CO, VA, SC, GA, KS, LA, MO
05-17-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08
Batch or Lot Expiration Information
Lot# 69MO EXP 05/13, 69SH EXP 05/13, 5KXZ EXP 05/12, 5RE1 EXP 05/12
