FDA Recalls Vancomycin Injectable Solution Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 8,252 bags of vancomycin injection nationwide after FDA inspection raised concerns about product sterility. Affected lots expire May through June 2023.
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 injectable medication with sterility assurance concerns. No illnesses or injuries reported in the source. Per the rubric, risk-of-harm products where injury has not been documented qualify as High (3) severity.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 8,252 bags of vancomycin added to 0.9% sodium chloride solution (1.75 g/500 mL, 3.5 mg/mL) distributed nationwide in the USA. The recall was initiated after an FDA inspection raised questions about the sterility of these injectable products.
Injectable medications require sterility to prevent contamination and patient harm. The loss of sterility assurance in these products poses a potential risk. Multiple lots are affected, with expiration dates ranging from May 3, 2023 through June 26, 2023. Affected products are identified by NDC 71285-7060-1.
Patients and healthcare providers who possess affected lots should not use these products. Patients should consult their healthcare provider, and healthcare providers should contact the manufacturer for replacement products and further guidance.
The recalled product
- Product
- vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7060-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- 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 # 37-884152
- 37-884158
- Exp 05/03/2023
- 37-885300
- 37-885302
- 37-885307
- Exp 05/08/2023
- 37-887418
- 37-887431
- 37-887432
- Exp 05/16/2023
- 37-888850
- 37-888852
- 37-888853
- Exp 05/22/2023
- 37-889188
- Exp 05/23/2023
- 37-890892
- 37-890894
- 37-890897
Distribution
Distributed nationwide across the United States.
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