Agency classClass IIOur severity:High FDA (Drugs)·D-0969-2023·Announced 2023-08-09

Vancomycin IV bags recalled due to sterility assurance failure

Central Admixture Pharmacy Services is recalling 6,782 bags of vancomycin IV bags distributed nationwide due to lack of validation data for decontamination cycles, which compromises 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 classified this as Class II. The source reports no illnesses or injuries. However, the hazard of lack of sterility assurance for an intravenous medication represents a significant risk of harm to patients. This meets the High criterion: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 6,782 bags of vancomycin 1.75g in 0.9% sodium chloride 500mL IV bags distributed nationwide. The product is identified by NDC 72196-7060-1 and includes multiple lot numbers with expiration dates from July 2023 through September 2023.

The recall is due to a lack of validation data for decontamination cycles used during product preparation. This validation failure means there is no assurance that these IV bags meet sterility requirements.

Healthcare facilities and patients should stop use of the recalled lots immediately and contact their healthcare provider or pharmacist. Patients with questions may contact Central Admixture Pharmacy Services, Inc. at 2200 South 43rd Avenue, Phoenix, AZ 85043.

The recalled product

Product: vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7060-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Intravenous
Hazard: sterility-failure
contamination-risk
Affected units: 6,782

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: 36-239519
36-239518
Exp. 7/12/2023
36-239992
Exp. 7/13/2023
36-240844
Exp. 7/18/2023
36-241983
Exp. 7/24/2023
36-243151
Exp. 7/27/2023
36-243950
Exp. 7/31/2023
36-245538
36-245544
Exp. 8/2/2023
36-247881
Exp. 8/10/2023
36-251053
Exp. 8/24/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 95 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 95 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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