QuVa Pharma Recalls Subpotent Oxytocin Injection Bags
QuVa Pharma is recalling 648 bags of oxyTOCIN 30 Units/500 mL because the product did not contain the active drug.
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 recall as Class II. According to the rubric, an FDA Class II recall with significant injury/property-damage reports or structural defects is Severe. While no specific injuries are reported in the text, the absence of the active drug in a prescription IV medication is a significant failure that fits the Severe category for Class II drug recalls.
Plain-English summary
QuVa Pharma, Inc. is recalling 648 bags of oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use. The product is identified by NDC 70092-1068-07 and Lot # 30010515. The recall was initiated because the product was found to be subpotent, meaning it did not contain the active drug.
The affected product was distributed nationwide in the United States. This is a prescription-only medication intended for intravenous use. 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.
Healthcare providers and patients should stop using the affected lots of oxyTOCIN and contact QuVa Pharma for further instructions or a replacement. Consumers should not use this product if they have it in their possession.
The recalled product
- Product
- oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07
- Manufacturer
- QuVa Pharma, Inc.
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 648
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)
- Lot#: 30010515
Distribution
Distributed nationwide across the United States.
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