Phenylephrine IV Bags Recalled Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 390 bags of Phenylephrine 20 mg 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 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 significant risks such as lack of sterility assurance in injectable products.
Plain-English summary
CMC Enterprise Pharmacy is recalling 390 bags of Phenylephrine 20 mg NS 250 mL. The recall was initiated because the product lacks sterility assurance. The affected product was manufactured by Enterprise Pharmacy in Charlotte, North Carolina.
The recall includes five specific lots with expiration dates ranging from April 14, 2019, to April 20, 2019. The lot numbers are ED051911, ED081911, ED091910, ED101911, and ED111909. The product was distributed in North Carolina.
Healthcare providers and patients should stop using the affected product and contact the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Phenylephrine 20 mg 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
- 390
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 (5)
- Lots: ED051911 Exp. 4/14/2019
- ED081911 Exp. 4/17/2019
- ED091910 Exp. 4/18/2019
- ED101911 Exp. 4/19/2019
- ED111909 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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