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.
What this means for you
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
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.
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