Agency classClass IIOur severity:High FDA (Drugs)·D-0720-2023·Announced 2023-05-31

Injectable Vancomycin Admixture Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 27,780 bags of vancomycin injectable solution nationwide after an FDA inspection raised concerns about the product's sterility assurance.

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 for lack of sterility assurance in an injectable product. No illnesses or injuries have been reported. However, this is a risk-of-harm product where injury has not yet been reported; non-sterile injectable medications pose a potential risk of contamination and infection.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 27,780 bags of vancomycin 1.25 g added to 0.9% sodium chloride (5 mg/mL, 250 mL per bag) distributed nationwide. The recall was initiated after an FDA inspection called into question the sterility of the products, which are intended to be sterile injectable solutions.

The affected product includes multiple lot numbers (37-883407 through 37-893996) with expiration dates between May 1 and June 21, 2023. Healthcare facilities and other users should immediately cease use of products with these lot numbers and contact the manufacturer for instructions on return, replacement, and disposal.

The recalled product

Product: vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6074-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug
Hazard: lack-of-sterility
contamination-risk
Affected units: 27,780

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 # 37-883407
37-883436
Exp 05/01/2023
37-883796
37-883797
37-883800
37-883802
37-883806
Exp 05/02/2023
37-884162
37-884163
Exp 05/03/2023
37-885332
37-885336
37-885337
Exp 05/08/2023
37-885749
37-885753
37-885755
Exp 05/09/2023

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 →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Same hazard · lack of sterility