Agency classClass IIOur severity:High FDA (Drugs)·D-0744-2023·Announced 2023-05-31

FDA Recalls NORepinephrine Injection Due to Sterility Concerns

Central Admixture Pharmacy Services recalled 6,414 bags of NORepinephrine injection nationwide after an FDA inspection questioned the sterility of the product. Healthcare facilities should stop using and quarantine affected lots.

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 a sterile injectable pharmaceutical product where FDA inspection found lack of sterility assurance. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3. No illnesses or deaths have been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 6,414 bags of NORepinephrine added to 0.9% sodium chloride injection (32 mcg/mL, 250 mL bags) nationwide. The recall was initiated after an FDA inspection raised concerns about the sterility of products marketed as sterile.

The affected product is NDC 71285-8096-1 from the manufacturer's Allentown, Pennsylvania facility. Multiple lot numbers with expiration dates from April 2023 through July 2023 are included in the recall.

Healthcare providers and facilities should immediately stop using any affected lots and quarantine remaining inventory. Consult the FDA or the manufacturer for guidance on affected products and any steps needed to address previously administered doses.

The recalled product

Product: NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8096-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable
Hazard: sterility-failure
Affected units: 6,414

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 # 37-882989
Exp 04/28/2023
37-883827
37-883829
37-883830
37-883833
37-883858
Exp 05/02/2023
37-884758
Exp 05/05/2023
37-885357
Exp 05/08/2023
37-885748
37-885751
Exp 05/09/2023
37-887409
37-887410
Exp 05/16/2023
37-888863
37-888867

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 →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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