Injectable Oxytocin Lactated Ringer's Solution Recalled for Sterility Concerns
Central Admixture Pharmacy Services is recalling 21,871 bags of injectable oxytocin mixed with Lactated Ringer's solution nationwide due to sterility assurance failures identified during an FDA inspection.
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 with no reported illnesses or injuries. The hazard—compromised sterility assurance for injectable medications—poses serious risk to patients, but lack of confirmed adverse events limits the classification to High rather than Severe.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 21,871 bags of injectable oxytocin 30 units mixed with Lactated Ringer's 500 mL solution, a prescription-only medication. The recall was initiated following an FDA inspection that questioned whether the manufacturer could assure the sterility of the product, as required for injectable medications.
The product was distributed nationwide across the United States. Healthcare providers and facilities that received affected lots should immediately cease use. Affected lot numbers include 37-889853, 37-889854, 37-889856 (expiring April 30, 2023), 37-890087, 37-890088, 37-890095, 37-890098, 37-890100, 37-890107, 37-890109 (expiring May 3, 2023), and multiple additional lots with expiration dates through June 10, 2023.
Patients and healthcare providers should not use any units from the affected lots. All remaining product should be returned to the manufacturer or disposed of according to applicable regulations. For more information, contact Central Admixture Pharmacy Services at 6580 Snowdrift Rd., Suite 100, Allentown, PA 18106.
The recalled product
- Product
- oxyTOCIN 30 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 71285-6039-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 21,871
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 # 37-889853
- 37-889854
- 37-889856
- Exp 04/30/2023
- 37-890087
- 37-890088
- 37-890095
- 37-890098
- 37-890100
- 37-890107
- 37-890109
- Exp 05/03/2023
- 37-890876
- 37-890878
- 37-890885
- 37-890891
- Exp 05/05/2023
- 37-891572
- Exp 05/07/2023
- 37-892504
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.
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