NORepinephrine Injectable Solution Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 2890 bags of NORepinephrine injection due to lack of sterility assurance following FDA inspection. The product, distributed nationwide, has affected lots with expiration dates through July 2023.
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: This product poses a risk of harm as a sterile injectable where sterility assurance failed, with no illnesses reported to date. It meets the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 2890 bags of NORepinephrine added to dextrose 5% (16 mg/250 mL). The recall follows an FDA inspection that raised questions about whether the product meets required sterility standards.
Injectable medications must be sterile to prevent serious infections when administered to patients. The FDA inspection could not assure that these products maintained the sterility required for safe injection. Multiple lot numbers are affected with expiration dates ranging from April 28, 2023 through July 2, 2023.
The recalled product was distributed nationwide. Healthcare providers and patients who may have this product should not use it.
Healthcare facilities should quarantine affected lots and contact Central Admixture Pharmacy Services, Inc. or the FDA for further instructions regarding this recall.
The recalled product
- Product
- NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8095-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable medication
- Hazard
- lack-of-sterility
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 # 37-883007
- 37-883015
- 37-883017
- Exp 04/28/2023
- 37-883236
- Exp 04/30/2023
- 37-884187
- 37-884189
- 37-884190
- Exp 05/03/2023
- 37-884567
- 37-884568
- 37-884569
- Exp 05/04/2023
- 37-887789
- 37-887790
- Exp 05/17/2023
- 37-889142
- 37-889143
- 37-889144
Distribution
Distributed nationwide across the United States.
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