Morphine Sulfate Inhalation Vials Recalled for Lack of Sterility Assurance
Anderson Compounding Pharmacy is recalling Morphine Sulfate 5 mg/3mL inhalation vials due to a lack of sterility assurance. The recall covers 60 vials distributed nationwide.
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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in an injectable/inhalable medication) are categorized as Severe (Score 4), particularly when the agency classification is explicitly Class II.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling Morphine Sulfate 5 mg/3mL Inhalation, 3 mL Vials. The recall is being conducted because the product lacks sterility assurance. The affected product consists of 60 vials and was distributed nationwide.
The recall includes all lots of the product. The source text does not specify a particular expiration date or lot number beyond the indication that all lots are affected.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Morphine Sulfate 5 mg/3mL Inhalation, 3 mL Vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 60
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 68 recalled by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy 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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