Agency classClass IIOur severity:High FDA (Drugs)·D-0967-2023·Announced 2023-08-09

Vancomycin IV Bags Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling 6,772 bags of vancomycin IV solution nationwide due to lack of assurance of sterility. Validation data for decontamination cycles is lacking.

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 classified as FDA Class II. While no illnesses or injuries are reported in the source, this involves a sterility assurance issue for an intravenous medication—a high-risk product where contamination could cause serious harm. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 6,772 bags of vancomycin 1.5 g/500 mL added to 0.9% sodium chloride (3 mg/mL), Rx only. The product is manufactured by Central Admixture Pharmacy Services, Inc. located in Phoenix, Arizona.

The recall is due to a lack of assurance of sterility. Validation data for decontamination cycles is lacking, which creates uncertainty about whether the products have been adequately sterilized for safe intravenous use.

The affected product was distributed nationwide in the United States. Multiple lot numbers are included in the recall, with expiration dates ranging from July 10, 2023, through September 13, 2023.

The recalled product

Product: vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6176-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable / IV Medication
Hazard: contamination-risk
sterility-assurance
Affected units: 6,772

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: 36-238968
36-238985
36-238992
36-238998
Exp. 7/10/2023
36-240784
36-240785
36-240786
36-240787
Exp. 7/17/2023
36-240840
36-240842
Exp. 7/18/2023
36-243157
Exp. 7/27/2023
36-243953
Exp. 7/31/2023
36-251050
36-251051
36-251059

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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Same hazard · contamination risk