Rocuronium Injection Syringes Recalled for Sterility Assurance Deficiency
FDA recalls 77,554 rocuronium syringes nationwide due to lack of sterility assurance and inadequate validation data for sterilization processes. The drug was repackaged by Central Admixture Pharmacy Services, Inc.
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: FDA Class II recall of an injectable drug with sterility deficiency. Rocuronium is a high-risk injectable medication, and lack of sterility assurance creates potential contamination risk. No illnesses or injuries reported in the source text.
Plain-English summary
Rocuronium 50 mg/5 mL (10 mg/mL) injection syringes manufactured by Central Admixture Pharmacy Services, Inc. are being recalled. The FDA initiated this recall due to the manufacturer's lack of assurance of sterility. Specifically, validation data for decontamination cycles is lacking, which means the sterilization process has not been adequately validated.
Approximately 77,554 syringes are affected by this recall. The syringes were distributed nationwide in the United States. Multiple lot numbers are affected with expiration dates ranging from July 2023 to August 2023.
Healthcare facilities and providers should immediately stop using any rocuronium syringes from the affected lots and contact Central Admixture Pharmacy Services for instructions on returning or disposing of the recalled product. For a complete list of affected lot numbers, consult the FDA's official recall notice.
The recalled product
- Product
- rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable Drug
- Hazard
- sterility-failure
- 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 (20)
- Lot: 36-238805
- 36-238806
- 36-238808
- 36-238809
- 36-238810
- 36-238811
- Exp. 7/10/2023
- 36-239229
- 36-239319
- 36-239320
- 36-239321
- 36-239322
- Exp. 7/11/2023
- 36-239453
- 36-239454
- 36-239455
- Exp. 7/12/2023
- 36-239851
- 36-239852
- Exp. 7/13/2023
Distribution
Distributed nationwide across the United States.
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