Multi-event November 2010 FDA Recall Drug by Physicians Total Care, Inc

This Multi-event Class I drug recall was voluntarily initiated by Physicians Total Care, Inc on November 10, 2010 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in FL and the recall is currently terminated.

Reported Recall Events

D-1385-2012 TERMINATED D-1386-2012 TERMINATED

Recall Number: D-1385-2012

Reason for Recall
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Initiated
11-10-2010
Reported
06-27-2012
Quantity
540 tablets (9 containers of 60 tablets each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61233
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-24-2012
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00

Batch or Lot Expiration Information

Batch# PTC Drug Number: 4033. PTC Batch Number: 65IT. Batch Date: 10/13/2010. Expiration Date: 11/30/2011. NDC: 54868-4033-00

Recall Number: D-1386-2012

Reason for Recall
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Initiated
11-10-2010
Reported
06-27-2012
Quantity
600 tablets (5 containers of 120 tablets each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61233
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-24-2012
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00

Batch or Lot Expiration Information

Batch# PTC Drug Number: 4973. PTC Batch Number: 65J2. Batch Date: 10/13/2010. Expiration Date: 06/30/2012. NDC: 54868-4973-00