Agency classClass IIOur severity:High FDA (Drugs)·D-0952-2023·Announced 2023-08-09

Glycopyrrolate Injectable for Anesthesia Recalled Due to Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling 770 syringes of glycopyrrolate injectable medication nationwide due to lack of validation data for sterilization processes. The product may not meet required sterility standards for safe anesthesia use.

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 FDA Class II recall of an injectable medication involves a significant risk-of-harm product where sterility cannot be assured due to missing validation data. No illnesses or injuries have been reported, and the hazard is assurance-based rather than confirmed contamination, therefore scoring High rather than Severe.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 770 syringes of glycopyrrolate 1 mg/5 mL (0.2 mg/mL) injectable solution intended for anesthesia use. The affected product was distributed nationwide to healthcare facilities.

The recall was initiated due to lack of assurance of sterility and missing validation data for decontamination cycles. The manufacturer could not adequately verify that the sterilization processes used in preparing these medications meet required standards.

Healthcare providers and patients should stop using the affected lots immediately. The specific lot numbers are: 36-247022 (expires 08/07/2023), 36-239877 (expires 07/13/2023), 36-241448 (expires 07/20/2023), and 36-251782 (expires 08/29/2023). Contact your pharmacy or healthcare facility if you received this product.

The recalled product

Product: glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6084-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Injectable Anesthesia
Hazard: lack-of-sterility
contamination-risk
Affected units: 770

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 (8)

Lot: 36-247022
Exp 08/07/2023
36-239877
Exp 07/13/2023
36-241448
Exp 07/20/2023
36-251782
Exp 08/29/2023

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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