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.
What this means for you
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
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.
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