Agency classClass IIOur severity:High FDA (Drugs)·D-0736-2023·Announced 2023-05-31

FDA Recalls Vancomycin Injectable Solution Due to Sterility Concerns

Central Admixture Pharmacy Services is recalling 8,252 bags of vancomycin injection nationwide after FDA inspection raised concerns about product sterility. Affected lots expire May through June 2023.

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 of injectable medication with sterility assurance concerns. No illnesses or injuries reported in the source. Per the rubric, risk-of-harm products where injury has not been documented qualify as High (3) severity.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 8,252 bags of vancomycin added to 0.9% sodium chloride solution (1.75 g/500 mL, 3.5 mg/mL) distributed nationwide in the USA. The recall was initiated after an FDA inspection raised questions about the sterility of these injectable products.

Injectable medications require sterility to prevent contamination and patient harm. The loss of sterility assurance in these products poses a potential risk. Multiple lots are affected, with expiration dates ranging from May 3, 2023 through June 26, 2023. Affected products are identified by NDC 71285-7060-1.

Patients and healthcare providers who possess affected lots should not use these products. Patients should consult their healthcare provider, and healthcare providers should contact the manufacturer for replacement products and further guidance.

The recalled product

Product: vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7060-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable / Sterile Preparation
Hazard: sterility-failure
contamination-risk
Affected units: 8,252

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 # 37-884152
37-884158
Exp 05/03/2023
37-885300
37-885302
37-885307
Exp 05/08/2023
37-887418
37-887431
37-887432
Exp 05/16/2023
37-888850
37-888852
37-888853
Exp 05/22/2023
37-889188
Exp 05/23/2023
37-890892
37-890894
37-890897

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.

See all →

Moderate
Pediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
Severe
Pediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
Severe
Injectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
High
Ephedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
High
Fentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11

Same hazard · sterility failure