Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotent Drug Concerns
Advanced Pharma Inc. is recalling 12 bags of Oxytocin 10 Units Injectable Solution because the product may contain higher concentrations than labeled.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Advanced Pharma Inc. is recalling 12 bags of Oxytocin 10 Units added to NS 1000 mL Injectable Solution. The product is identified by Lot 12/20/18 1056 73099P and has a beyond-use date of 02/03/2019. The recall was initiated because the product is classified as a superpotent drug, meaning it may contain concentrations of oxytocin higher than what is represented on the label.
The affected product is a sterile single-use bag containing approximately 1001 mL of solution, intended for prescription use only. It was distributed nationwide in the USA. The recall is classified as Class III by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Healthcare providers and facilities that have received this product should stop using it and contact Advanced Pharma Inc. for further instructions. Consumers should not use this product and should contact their healthcare provider if they have questions regarding its use.
The recalled product
- Product
- Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 12
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: 12/20/18 1056 73099P
- BUD: 02/03/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Advanced Pharma Inc. 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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