FDA Recalls oxyTOCIN IV Bags Over Sterility Assurance Failure
FDA recalled 751 bags of oxyTOCIN added to Lactated Ringer's IV solution nationwide due to lack of validation data for decontamination cycles, which left sterility assurance unconfirmed.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (injectable medication) where injury has not yet been reported. The lack of validation data for decontamination cycles in an IV medication presents a significant sterility risk, but no illnesses or injuries are reported in the source material.
Plain-English summary
Central Admixture Pharmacy Services, Inc. recalled 751 bags of oxyTOCIN 15 units added to Lactated Ringer's 250 mL IV bags distributed nationwide in the USA. The recall was issued because validation data for decontamination cycles is lacking, meaning there is no assurance that the sterility of the product was adequately maintained during manufacturing.
Affected lots are: 36-247802 and 36-247803 (expiration 7/15/2023) and 36-254395 (expiration 8/10/2023). The product has NDC 72196-6037-1 and was manufactured by Central Admixture Pharmacy Services, Inc., located at 2200 South 43rd Avenue, Phoenix, AZ 85043.
Patients who received this product should contact their healthcare provider to determine if they were affected and to discuss any appropriate follow-up care.
The recalled product
- Product
- oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:72196-6037-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV Solution
- Affected units
- 751
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 (5)
- Lot: 36-247802
- 36-247803
- Exp. 7/15/2023
- 36-254395
- Exp. 8/10/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 recalled by Central Admixture Pharmacy Services, 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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