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.
The agency’s classification
FDA (Drugs): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Physicians Total Care, Inc
- Category
- Drug — Prescription Medication
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.
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