Agency classClass IIOur severity:High FDA (Drugs)·D-0710-2023·Announced 2023-05-31

Oxytocin Injectable Solution Recalled for Sterility Assurance Questions

Central Admixture Pharmacy Services is recalling oxytocin injectable solution after FDA inspection questioned sterility. Over 104,000 bags distributed nationwide are affected.

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 an FDA Class II drug recall for a high-risk injectable product with lack of sterility assurance. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet occurred, which per the rubric is rated High (3).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling oxytocin 30 units added to 0.9% sodium chloride 500 mL per bag. This is a prescription-only injectable medication. The recall affects approximately 104,807 bags with multiple lot numbers and expiration dates ranging from April to June 2023.

The recall was initiated after an FDA inspection raised questions about whether these products maintain the required sterility assurance. For injectable medications, lack of sterility assurance poses a risk of infection to patients who receive the medication.

The recalled product was distributed nationwide to healthcare facilities and pharmacies. Healthcare providers should immediately quarantine affected lots and contact their suppliers about replacement products. Patients or providers who have received this medication should not use it and should consult with healthcare providers about appropriate follow-up.

The recalled product

Product: oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6044-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable / Prescription
Hazard: sterility-failure
infection-risk
Affected units: 104,807

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 (20)

Lot # 37-883041
37-883043
37-883044
37-883045
37-883047
37-883059
37-883060
37-883067
37-883071
37-883072
37-883131
37-883185
Exp 04/28/2023
37-883492
37-883499
37-883501
37-883503
37-883514
37-883525
37-883526

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 108 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.

See all 108 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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