D-1385-2012 Class I Terminated
FDA drug recall D-1385-2012 was initiated by Physicians Total Care, Inc on November 10, 2010 and is designated Class I. Reason for recall: Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. The recall status is terminated (terminated July 24, 2012). Affected quantity: 540 tablets (9 containers of 60 tablets each).
Recall Details
- Product Type
- Drugs
- Report Date
- June 27, 2012
- Initiation Date
- November 10, 2010
- Termination Date
- July 24, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 540 tablets (9 containers of 60 tablets each)
Product Description
Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00
Reason for Recall
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Distribution Pattern
FL
Code Information
PTC Drug Number: 4033. PTC Batch Number: 65IT. Batch Date: 10/13/2010. Expiration Date: 11/30/2011. NDC: 54868-4033-00