Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotency
Advanced Pharma Inc. is recalling 672 bags of Oxytocin 20 Units Injectable Solution because the product may contain higher concentrations than labeled.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
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 indicates is typically a score of 1 or 2. The hazard involves a labeling/potency discrepancy without reported injuries, fitting the Moderate category for minor labeling errors or low-risk issues.
Plain-English summary
Advanced Pharma Inc. is recalling 672 bags of Oxytocin 20 Units added to NS 1000 mL Injectable Solution. The recall involves sterile single-use bags with NDC 42852-703-99, manufactured by Avella of Houston. The affected lots are 12/14/18 1482 70399P and 12/14/18 1610 70399P, both with a best-use date of 02/27/19.
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. This discrepancy could result in patients receiving a higher dose than intended.
The product was distributed nationwide in the USA. Healthcare providers and patients should discontinue use of the affected lots and contact Advanced Pharma Inc. for further instructions or returns.
The recalled product
- Product
- Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 672
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 (3)
- Lots: 12/14/18 1482 70399P
- BUD: 02/27/19
- 12/14/18 1610 70399P
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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