Vancomycin IV Bags Recalled Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 737 bags of Vancomycin 1250 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
CMC Enterprise Pharmacy is recalling 737 bags of Vancomycin 1250 mg in NS 250 mL. The recall is being conducted because of a lack of sterility assurance for the product. The affected lots were manufactured by Enterprise Pharmacy in Charlotte, North Carolina.
The recall covers specific lots with expiration dates ranging from April 13, 2019, to April 20, 2019. The distribution pattern for these products is limited to North Carolina. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected products and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Manufacturer
- CMC Enterprise Pharmacy
- Category
- Drug — Antibiotic
- Affected units
- 737
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 (6)
- Lots: ED041915 Exp. 4/13/2019
- ED051915 Exp. 4/14/2019
- ED081915 Exp. 4/17/2019
- ED091915 Exp. 4/18/2019
- ED101915 Exp. 4/19/2019
- ED111913 Exp. 4/20/2019
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 32 recalled by CMC Enterprise Pharmacy 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.
See all 32 products in this recall →Related recalls
Same manufacturer · CMC Enterprise Pharmacy
See all →- SevereCMC Enterprise Pharmacy Recalls CeFAZolin Due to Lack of Sterility Assurance
FDA (Drugs) · 2019-05-01
- SevereCMC Enterprise Pharmacy Recalls Oxytocin Bags Due to Sterility Concerns
FDA (Drugs) · 2019-05-01
- SevereCMC Enterprise Pharmacy Recalls Vancomycin Bags Due to Sterility Concerns
FDA (Drugs) · 2019-05-01
- SevereDiltiazem 250 mg IV Bags Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-05-01
- SevereCMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns
FDA (Drugs) · 2019-05-01
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereBaptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns
FDA (Drugs) · 2016-06-08
- SevereVancomycin HCl IV Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2022-02-02
- HighVancomycin IV Bags Recalled Over Sterility Assurance Concerns Nationwide
FDA (Drugs) · 2023-08-09
- SevereVancomycin HCl Injection Recall for Lack of Sterility Assurance
FDA (Drugs) · 2022-02-02
- HighVancomycin Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighBaptist Health Recalls Vancomycin Bags Due to Sterility Concerns
FDA (Drugs) · 2016-06-08