Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care...
FDA Recall #D-1385-2012 — Class I — November 10, 2010
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.
Recalling Firm
Physicians Total Care, Inc — Tulsa, OK
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
540 tablets (9 containers of 60 tablets each)
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated