CMC Enterprise Pharmacy Recalls Vancomycin Bags Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 2000 mg in 0.9% Sodium Chloride due to a lack of sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bags. The recall was initiated because of a lack of sterility assurance for the product.
The affected product was distributed in North Carolina. The recall includes specific lots with expiration dates ranging from April 13, 2019, to April 20, 2019. The product was manufactured by Enterprise Pharmacy in Charlotte, North Carolina.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Manufacturer
- CMC Enterprise Pharmacy
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 532
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: ED041919 Exp. 4/13/2019
- ED051919 Exp. 4/14/2019
- ED041919 Exp. 4/17/2019
- ED091919 Exp. 4/18/2019
- ED101919 Exp. 4/19/2019
- ED111917 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.
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