Vancomycin 1500 mg Bags Recalled Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 715 bags of Vancomycin 1500 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.
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 source text identifies the recall as FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterility assurance issues in injectable medications.
Plain-English summary
CMC Enterprise Pharmacy is recalling 715 bags of Vancomycin 1500 mg in NS 250 mL. The recall was initiated because the product lacks sterility assurance. The affected lots are ED041916, ED051916, ED081916, ED091916, ED101916, and ED111914, with expiration dates ranging from April 13, 2019, to April 20, 2019.
The recalled product was distributed in North Carolina. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected product and contact CMC Enterprise Pharmacy for further instructions or a refund.
The recalled product
- Product
- Vancomycin 1500 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
- Hazard
- Affected units
- 715
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: ED041916 Exp. 4/13/2019
- ED051916 Exp. 4/14/2019
- ED081916 Exp. 4/17/2019
- ED091916 Exp. 4/18/2019
- ED101916 Exp. 4/19/2019
- ED111914 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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