Morphine Injectable Recalled Due to Unvalidated Sterilization Process
Central Admixture Pharmacy Services recalls 1,235 morphine syringes nationwide due to lack of validation data for sterilization cycles, potentially compromising sterility.
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 is an FDA Class II recall of an injectable medication with a critical sterilization validation failure. While no illnesses or injuries have been reported, the lack of validated sterilization processes presents a significant risk of harm through potential bacterial or fungal contamination, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling 1,235 syringes of morphine in 0.9% sodium chloride (50 mg/50 mL), distributed nationwide. The recall was initiated because the manufacturer lacks validation data for the sanitization cycles used in the manufacturing process.
The concern is the lack of assurance of sterility. Without proper validation of the sanitization process, the manufacturer cannot confirm that the sterilization is effective, which could potentially leave injectable products contaminated with bacteria or fungi.
The affected product lots are: 17-273353 (expires 8/31/2023), 17-270602 (expires 7/17/2023), 17-270706 (expires 7/18/2023), 17-271416 (expires 7/30/2023), 17-272049 (expires 8/9/2023), 17-272277 (expires 8/14/2023), and 17-273231 (expires 8/30/2023).
Patients and healthcare providers should not use affected syringes. Contact your pharmacy or healthcare provider for guidance on replacement or proper disposal.
The recalled product
- Product
- morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable Medication
- Affected units
- 1,235
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 (14)
- Lot: 17-273353
- Exp 8/31/2023
- 17-270602
- Exp 7/17/2023
- 17-270706
- Exp 7/18/2023
- 17-271416
- Exp 7/30/2023
- 17-272049
- Exp 8/9/2023
- 17-272277
- Exp 8/14/2023
- 17-273231
- Exp 8/30/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 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.
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