PharMEDium Recalls Oxytocin Injection Bags Due to Sterility Concerns
PharMEDium Services, LLC is recalling 24 bags of Oxytocin Injection due to a lack of assurance of sterility and potential endotoxin issues.
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 and involves a lack of assurance of sterility and potential endotoxin contamination, which poses a significant risk of serious injury or death.
Plain-English summary
PharMEDium Services, LLC is recalling 24 Viaflex bags of 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL. The product is prescription-only and was distributed to South Carolina, Florida, New York, and Washington.
The recall was initiated because three lots were released despite a failure to follow proper testing and investigation procedures. This lack of assurance of sterility means the product may be out of specification for endotoxin.
Healthcare providers and patients should stop using the affected product immediately. The specific lot number is 180040003D, with an expiration date of 3/18/18. Consumers should contact their healthcare provider for further instructions.
The recalled product
- Product
- 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 24
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 #: 180040003D
- Exp 3/18/18
Distribution
Part of a larger recall action
This product is one of 3 recalled by PharMEDium Services, LLC 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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