Fresenius Kabi Recalls Subpotent Oxytocin Injection Vials
Fresenius Kabi is recalling 221,600 vials of Oxytocin Injection, USP, due to a subpotent drug issue identified during a 15-month stability test.
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 adverse health consequences (subpotent drug) are categorized as Severe (Score 4), as they are not Class I but involve significant quality issues.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 221,600 vials of Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use. The product is identified by Lot # 6003648 with an expiration date of 6/2013. The recall is being conducted because the drug was found to be subpotent during a 15-month stability test.
The affected vials were distributed nationwide and in Puerto Rico. The product is a prescription-only medication manufactured by APP Pharmaceuticals, LLC, located in Schaumburg, IL, and recalled by Fresenius Kabi USA, LLC.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions. This recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 221,600
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 #: 6003648
- Exp. 6/2013
Distribution
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