Agency classClass IIOur severity:High FDA (Drugs)·D-0722-2023·Announced 2023-05-31

Vancomycin Injectable Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services recalls 9,037 bags of vancomycin injectable due to FDA concerns about sterility assurance. Products distributed nationwide may not meet required sterility standards.

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 sterile injectable products where sterility assurance has been called into question by FDA inspection. No illnesses have been reported, but the recall addresses a risk-of-harm scenario where contamination could cause serious patient injury.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 9,037 bags of vancomycin added to 0.9% sodium chloride injection (1.5 g/250 mL, NDC 71285-6076-1) distributed nationwide in the United States.

Following an FDA inspection, the agency raised questions about whether these products maintain the sterility required for injectable medications intended for intravenous use.

The recall affects healthcare facilities and providers who received affected lots, which have expiration dates ranging from May 1, 2023 through June 7, 2023. A complete list of affected lot numbers is available from the recalling firm.

Healthcare providers should identify any affected products in their inventory and discontinue use. They should contact Central Admixture Pharmacy Services, Inc. or the FDA with questions about the recall.

The recalled product

Product: vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6076-1.
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable / Admixture
Hazard: lack-of-sterility
contamination
Affected units: 9,037

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 # 37-883390
37-883435
Exp 05/01/2023
37-884157
Exp 05/03/2023
37-885716
37-886036
37-886039
Exp 05/09/2023
37-887499
37-887500
Exp 05/16/2023
37-887778
Exp 05/17/2023
37-888105
Exp 05/18/2023
37-889216
Exp 05/23/2023
37-890923
37-890928

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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