Injectable Vancomycin Admixture Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 27,780 bags of vancomycin injectable solution nationwide after an FDA inspection raised concerns about the product's sterility assurance.
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 for lack of sterility assurance in an injectable product. No illnesses or injuries have been reported. However, this is a risk-of-harm product where injury has not yet been reported; non-sterile injectable medications pose a potential risk of contamination and infection.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 27,780 bags of vancomycin 1.25 g added to 0.9% sodium chloride (5 mg/mL, 250 mL per bag) distributed nationwide. The recall was initiated after an FDA inspection called into question the sterility of the products, which are intended to be sterile injectable solutions.
The affected product includes multiple lot numbers (37-883407 through 37-893996) with expiration dates between May 1 and June 21, 2023. Healthcare facilities and other users should immediately cease use of products with these lot numbers and contact the manufacturer for instructions on return, replacement, and disposal.
The recalled product
- Product
- vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6074-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug
- 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 (20)
- Lot # 37-883407
- 37-883436
- Exp 05/01/2023
- 37-883796
- 37-883797
- 37-883800
- 37-883802
- 37-883806
- Exp 05/02/2023
- 37-884162
- 37-884163
- Exp 05/03/2023
- 37-885332
- 37-885336
- 37-885337
- Exp 05/08/2023
- 37-885749
- 37-885753
- 37-885755
- Exp 05/09/2023
Distribution
Distributed nationwide across the United States.
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