Morphine Sulfate Injection Recalled for Lack of Sterility Assurance
Pharmacy Plus, Inc. is recalling Morphine Sulfate 15mg/ml Injection due to a lack of assurance of sterility. The product was distributed in Mississippi.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for serious adverse health consequences (such as lack of sterility assurance in an injectable drug) are categorized as Severe (Score 4), particularly when no explicit 'no illness' statement is provided to lower the score to 3.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx. The recall is being conducted because of a lack of assurance of sterility. The affected product is identified by Lot# 396689 with a use-by date of 12-13-16.
The recall is classified as FDA Class II. The product was distributed in Mississippi (MS). The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Injectable
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 396689
- Use by 12-13-16
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 21 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder 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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