The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0709-2023·Announced 2023-05-31

Injectable oxyTOCIN solution recalled nationwide after sterility assurance questioned

Central Admixture Pharmacy Services is recalling oxyTOCIN 20 units in 0.9% sodium chloride injectable solution nationwide after an FDA inspection raised questions about the products' 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: This is an FDA Class II recall of a risk-of-harm product (sterile injectable medication) where no injuries or illnesses have been reported. The hazard is theoretical—a failure of sterility assurance in injectable drugs. Per the rubric, risk-of-harm products with no reported injury qualify for a severity of 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling oxyTOCIN 20 units added to 0.9% sodium chloride solution in 1,000 mL bags, distributed nationwide in the United States. The recall affects approximately 5,544 bags.

During an FDA inspection, questions were raised about whether the manufacturer could assure the sterility of the product. For injectable medications, which must remain sterile, this assurance is critical to safe use.

Healthcare facilities and providers should verify whether they have any of the affected lots in inventory using the lot numbers and expiration dates provided in the FDA recall notice. Affected products should be removed from use immediately.

The recalled product

Product
oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6043-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Injectable
Hazard
Affected units
5,544

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 # 37-883938
  • Exp 05/02/2023
  • 37-884910
  • 37-884915
  • Exp 05/07/2023
  • 37-886041
  • Exp 05/10/2023
  • 37-887515
  • 37-887520
  • Exp 05/16/2023
  • 37-888318
  • Exp 05/21/2023
  • 37-888847
  • Exp 05/22/2023
  • 37-890535
  • Exp 05/29/2023
  • 37-890957
  • Exp 05/30/2023
  • 37-891566
  • 37-891568

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 →

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Same manufacturer · Central Admixture Pharmacy Services, Inc.

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