The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1211-2019·Announced 2019-05-01

Diltiazem 250 mg IV Bags Recalled for Lack of Sterility Assurance

CMC Enterprise Pharmacy is recalling 1,475 bags of Diltiazem 250 mg in NS 250 mL 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 hospitalization reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the text, the classification of a sterile IV product lacking sterility assurance warrants a high severity rating due to the risk of infection.

Plain-English summary

CMC Enterprise Pharmacy is recalling 1,475 bags of Diltiazem 250 mg in NS 250 mL. The recall was initiated because the product lacks sterility assurance. The affected lots include EA161906, EA181906, EA231907, EA241907, EB061907, EB201907, and EC181909, with expiration dates ranging from April 16, 2019, to June 16, 2019.

The product was distributed in North Carolina. 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 recalled product and contact CMC Enterprise Pharmacy for further instructions or a replacement.

The recalled product

Product
Diltiazem 250 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 — IV Infusion
Hazard
Affected units
1,475

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 (7)

  • Lots: EA161906 Exp. 4/16/2019
  • EA181906 Exp. 4/18/2019
  • EA231907 Exp. 4/23/2019
  • EA241907 Exp. 4/24/2019
  • EB061907 Exp. 5/7/2019
  • EB201907 Exp. 5/21/2019
  • EC181909 Exp. 6/16/2019

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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