Agency classClass IIOur severity:High FDA (Drugs)·D-0706-2023·Announced 2023-05-31

Injectable oxyTOCIN and Lactated Ringer's Recalled Over Sterility Concerns

Central Admixture Pharmacy Services is recalling oxyTOCIN with Lactated Ringer's injection (14,362 bags) nationwide due to FDA inspection findings that questioned sterility assurance.

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: FDA Class II recall of injectable medications where FDA inspection questioned whether sterility standards could be assured. The source does not report any illnesses or injuries. The product meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling oxyTOCIN 20 units in Lactated Ringer's 1,000 mL bags distributed nationwide. The product is a prescription-only injectable medication.

After an FDA inspection, questions were raised about whether these products met sterility standards. The manufacturer could not provide assurance that these injectable medications were sterile as required.

The recall affects 14,362 bags with expiration dates from April 28, 2023 through June 10, 2023. Healthcare facilities and pharmacies that received affected lots should stop using them immediately and quarantine the inventory.

Healthcare providers should contact Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Suite 100, Allentown, PA 18106, for instructions on how to return the affected product.

The recalled product

Product: oxyTOCIN 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6038-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable Medication
Hazard: sterility-failure
Affected units: 14,362

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 # 37-889158
37-889187
37-889189
Exp 04/28/2023
37-889494
37-889507
37-889522
37-889525
37-889527
37-889608
Exp 04/29/2023
37-889906
37-889912
37-889913
Exp 04/30/2023
37-890110
37-890121
Exp 05/03/2023
37-891160
37-891162

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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Same hazard · sterility failure