Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotency
Advanced Pharma Inc. is recalling Oxytocin 30 Units Injectable Solution because the product may contain higher concentrations than labeled.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
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. The hazard involves potential superpotency, which is a quality issue rather than a direct contamination or acute injury risk.
Plain-English summary
Advanced Pharma Inc. is recalling 1,460 bottles of Oxytocin 30 Units added to NS 500 mL Injectable Solution. The product is a sterile single-use bag, prescription only, with NDC 42852-706-50. The affected lots were distributed nationwide in the USA.
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 lots include 11/27/18 3177 70650P, 11/27/18 6618 70650P, 11/28/18 7716 70650P, and 12/31/18 5698 70650P, with expiration dates ranging from February 10, 2019, to March 16, 2019.
Healthcare providers and patients should stop using the affected lots and contact Advanced Pharma Inc. for further instructions. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 1,460
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 (7)
- Lots: 11/27/18 3177 70650P
- BUD: 02/10/2019
- 11/27/18 6618 70650P
- 11/28/18 7716 70650P
- BUD: 02/12/19
- 12/31/18 5698 70650P
- BUD: 03/16/19
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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