Physicians Total Care Recalls Morphine Sulfate Tablets Due to Labeling Error
Physicians Total Care is recalling Morphine Sulfate tablets because bottles may be mislabeled, potentially containing the wrong formulation.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Physicians Total Care, Inc. is recalling Morphine Sulfate Immediate Release tablets, 30 mg, in bottles of 120 tablets. The recall is due to a labeling mix-up where bottles labeled as Immediate Release (IR) may actually contain Extended Release (ER) morphine, and vice versa.
The affected product is identified by NDC 54868-4973-00, PTC Drug Number 4973, and PTC Batch Number 65J2. The batch date is 10/13/2010, and the expiration date is 06/30/2012. The distribution pattern is listed as FL.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. This recall is classified as Class I by the FDA.
The recalled product
- 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
- 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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