The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0704-2023·Announced 2023-05-31

FDA Recalls Oxytocin Injectable Bags Due to Sterility Assurance Failure

FDA recalls 2,989 bags of oxytocin mixed with Lactated Ringer's solution nationwide due to lack of sterility assurance. An FDA inspection raised questions about whether the injectable drug met sterility standards.

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 an injectable pharmaceutical product where sterility assurance could not be confirmed. No illnesses or injuries have been reported. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 2,989 bags of oxytocin 10 units added to Lactated Ringer's 500 mL solution due to lack of assurance of sterility. The recall was initiated following an FDA inspection that raised questions about whether the products met required sterility standards for injectable pharmaceuticals.

Oxytocin is a hormone used in medical settings. Lactated Ringer's solution is an intravenous electrolyte replacement fluid. Both products are intended to be sterile for injection. If not sterile, patients could be exposed to microbial contamination.

The affected product was distributed nationwide. The recalled lots include: 37-891283 (Exp 05/06/2023), 37-892501 (Exp 05/12/2023), 37-894413 (Exp 05/19/2023), 37-896228 (Exp 05/26/2023), 37-896815, 37-896820, 37-896826 (Exp 05/28/2023), and 37-900126 (Exp 06/10/2023).

Healthcare facilities and healthcare providers should discontinue use of the recalled product immediately. Patients who have received these products should consult their healthcare provider. For recall information, contact Central Admixture Pharmacy Services, Inc. at 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106.

The recalled product

Product
oxyTOCIN 10 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6036-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Intravenous / Injectable
Hazard
Affected units
2,989

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 (14)

  • Lot # 37-891283
  • Exp 05/06/2023
  • 37-892501
  • Exp 05/12/2023
  • 37-894413
  • Exp 05/19/2023
  • 37-896228
  • Exp 05/26/2023
  • 37-896815
  • 37-896820
  • 37-896826
  • Exp 05/28/2023
  • 37-900126
  • Exp 06/10/2023

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 →

Related recalls

Same manufacturer · Central Admixture Pharmacy Services, Inc.

See all →

Same hazard · sterility failure

See all →

Similar recalls