Morphine Sulfate Injection Recalled Due to Defective Vials
Fresenius Kabi USA LLC is recalling 963,000 vials of Morphine Sulfate Injection because some vials are cracked, which compromises sterility assurance. The affected product was 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 FDA classified this as a Class II recall. Loss of sterility assurance in an injectable medication presents a significant risk of serious infection or adverse outcomes if non-sterile product is administered. Although no illnesses have been reported in the source text, the defect directly undermines the safety of an injectable pharmaceutical product.
Plain-English summary
Fresenius Kabi USA LLC is recalling Morphine Sulfate Injection, USP, 2 mg per mL, in 1 mL single-dose vials (NDC 63323-452-01) due to defective containers. Specifically, some vials are cracked, which leads to a loss of sterility assurance.
The recall affects 963,000 vials distributed nationwide across lot numbers 6023731, 6023732 (expiration 03/2023), 6024172, and 6024260 (expiration 06/2023). The product is manufactured by Fresenius Kabi USA LLC, located in Lake Zurich, Illinois.
Cracked vials pose a risk because they cannot maintain the sterile environment required for safe injection. Healthcare providers and patients using this medication should not use vials from the affected lots and should contact their supplier or Fresenius Kabi for guidance on replacement stock. Patients should consult their healthcare provider if they have questions about their treatment.
The recalled product
- Product
- MORPHINE SULFATE (MORPHINE SULFATE)
- Brand
- MORPHINE SULFATE
- Manufacturer
- Fresenius Kabi USA LLC
- Category
- Drug — Injectable Opioid
- Affected units
- 963,000
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 (6)
- Lot # 6023731
- 6023732
- Exp 03/2023
- 6024172
- 6024260
- Exp 06/2023
UPCs (2)
- 0363323454005
- 0363323451004
Distribution
Distributed nationwide across the United States.
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