The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1232-2019·Announced 2019-05-01

Phenylephrine IV Bags Recalled for Lack of Sterility Assurance

CMC Enterprise Pharmacy is recalling 215 bags of Phenylephrine 40 mg in 0.9% Sodium Chloride 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an IV product presents a significant risk of infection, aligning with the Severe classification for Class II drug recalls.

Plain-English summary

CMC Enterprise Pharmacy is recalling 215 bags of Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bags (160 mcg/mL). The recall is being conducted due to a lack of sterility assurance for the product.

The affected product was distributed in North Carolina. The specific lots involved are ED041912 (Exp. 4/13/2019), ED051912 (Exp. 4/14/2019), ED081912 (Exp. 4/17/2019), ED091911 (Exp. 4/18/2019), ED101912 (Exp. 4/19/2019), and ED111910 (Exp. 4/20/2019).

Healthcare providers and patients should stop using the affected product and contact the recalling firm for further instructions.

The recalled product

Product
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Manufacturer
CMC Enterprise Pharmacy
Category
Drug — IV Solution
Hazard
Affected units
215

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: ED041912 Exp. 4/13/2019
  • ED051912 Exp. 4/14/2019
  • ED081912 Exp. 4/17/2019
  • ED091911 Exp. 4/18/2019
  • ED101912 Exp. 4/19/2019
  • ED111910 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 →

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