CMC Enterprise Pharmacy Recalls Vancomycin Bags Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 1000 mg in NS 250 mL due to a lack of sterility assurance. The affected lots were 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 recall is classified as FDA Class II and involves a lack of sterility assurance in an injectable medication, which poses a risk of serious health consequences such as infection, meeting the criteria for a Severe rating.
Plain-English summary
CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 1000 mg in NS 250 mL. The recall was initiated because of a lack of sterility assurance for the product. The medication was manufactured by Enterprise Pharmacy in Charlotte, North Carolina.
The recall affects specific lots with expiration dates ranging from April 13, 2019, to April 20, 2019. The affected lot numbers are ED041918, ED051918, ED081918, ED091918, ED101918, and ED111916. The product was distributed in North Carolina.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Vancomycin 1000 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 — Injectable Medication
- 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: ED041918 Exp. 4/13/2019
- ED051918 Exp. 4/14/2019
- ED081918 Exp. 4/17/2019
- ED091918 Exp. 4/18/2019
- ED101918 Exp. 4/19/2019
- ED111916 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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