Agency classClass IIOur severity:High FDA (Drugs)·D-0718-2023·Announced 2023-05-31

Vancomycin Injectable Solution Recalled Due to Sterility Assurance Concerns Nationwide

Central Admixture Pharmacy Services is recalling 3,075 bags of vancomycin injectable solution nationwide due to lack of assurance of sterility following an FDA inspection.

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 with no reported illnesses or injuries and a theoretical hazard (lack of sterility assurance rather than confirmed contamination), which per the rubric means the score is at most 3. This qualifies as a risk-of-harm product (sterile injectable) where injury has not yet been reported, placing it at the High (3) level.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling vancomycin added to 0.9% sodium chloride solution (750 mg/250 mL concentration, 250 mL per bag, NDC 71285-6071-1) nationwide. The recall affects 3,075 bags with specific lot numbers and expiration dates ranging from May 3, 2023 to June 14, 2023.

The recall was initiated following an FDA inspection that determined there was insufficient assurance of sterility for these products, which are manufactured as sterile injectables intended for intravenous use. Non-sterile injectables may pose a risk of serious infection to patients.

The product was distributed nationwide in the United States.

The recalled product

Product: vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6071-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable / IV Solution
Hazard: sterility-failure
infection-risk
Affected units: 3,075

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 (15)

Lot # 37-884161
Exp 05/03/2023
37-885995
37-885997
Exp 05/10/2023
37-887729
Exp 05/17/2023
37-889595
Exp 05/24/2023
37-891272
Exp 05/31/2023
37-892162
Exp 06/05/2023
37-894716
Exp 06/14/2023

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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