The Recall Desk
SevereFDA (Drugs)·D-1385-2012·Announced 2012-06-27

Physicians Total Care Recalls Morphine Sulfate Extended Release Tablets Due to Labeling Error

Physicians Total Care is recalling Morphine Sulfate Extended Release tablets because bottles may be mislabeled as Immediate Release or vice versa.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric. The hazard involves a critical medication mix-up between immediate and extended-release opioids.

Plain-English summary

Physicians Total Care, Inc. is recalling Morphine Sulfate Extended Release tablets, 30 mg, 60 tablet bottles. The recall is due to a labeling error where bottles labeled to contain Morphine Sulfate Immediate Release (IR) may actually contain Morphine Sulfate Extended Release (ER), and bottles labeled as ER may contain IR.

The affected product is identified by NDC 54868-4033-00, PTC Drug Number 4033, and PTC Batch Number 65IT. The batch date is 10/13/2010, and the expiration date is 11/30/2011. The distribution pattern is listed as FL.

Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the description. They should contact their pharmacist or the recalling firm for further instructions on how to return or dispose of the medication.

The recalled product

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

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Physicians Total Care, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →