The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1217-2019·Announced 2019-05-01

Enterprise Pharmacy Recalls Nifedipine Bags Due to Sterility Concerns

CMC Enterprise Pharmacy is recalling 1,783 bags of Nifedipine 25 mg in NS 250 mL due to a lack of sterility assurance. The affected products 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 infection or adverse health consequences.

Plain-English summary

CMC Enterprise Pharmacy is recalling 1,783 bags of NICARdipine 25 mg in NS 250 mL EXCEL bag. The recall was initiated because of a lack of sterility assurance in the manufacturing process. The affected products were distributed in North Carolina.

The recall includes specific lots with expiration dates ranging from April 16, 2019, to June 25, 2019. The lot numbers are EA161909, EA211907, EB041906, EB111908, EB181907, EB251910, EC111908, EC201909, EC261909, and EC271919. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should stop using the affected products and contact CMC Enterprise Pharmacy for further instructions or a replacement. Consumers should not use the recalled bags and should return them to the pharmacy where they were obtained.

The recalled product

Product
NICARdipine 25 mg in NS 250 mL EXCEL 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
1,783

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 (10)

  • Lots: EA161909 Exp. 4/16/2019
  • EA211907 Exp. 4/21/2019
  • EB041906 Exp. 5/5/2019
  • EB111908 Exp. 5/12/2019
  • EB181907 Exp. 5/19/2019
  • EB251910 Exp. 5/26/2019
  • EC111908 Exp. 6/9/2019
  • EC201909 Exp. 6/18/2019
  • EC261909 Exp. 6/24/2019
  • EC271919 Exp. 6/25/2019

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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