The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0019-2018·Announced 2017-11-01

FDA Recalls Hydromorphone Syringes Due to Sterility Concerns

Banner Pharmacy Services is recalling specific lots of Hydromorphone HCl syringes because the FDA determined there is a lack of assurance of sterility.

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. According to the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility in an injectable drug) is categorized as Severe.

Plain-English summary

Banner Pharmacy Services, LLC is recalling 1,658 syringes of Hydromorphone HCl 10 mg (0.2mg/ml) in 0.9% Sodium Chloride. The recall was initiated because the U.S. Food and Drug Administration determined there is a lack of assurance of sterility for the product.

The affected product is identified by NDC 7025001001 and was distributed nationwide within the United States. The recall covers specific lots with expiration dates ranging from October 15, 2017, to February 1, 2018. The source text does not specify the exact number of units distributed to individual facilities or the specific states affected beyond the nationwide scope.

Consumers and healthcare providers should stop using the recalled syringes and contact their pharmacist or Banner Pharmacy Services 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
Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001.
Manufacturer
Banner Pharmacy Services, LLC
Category
Drug — Injectable
Hazard
Affected units
1,658

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 (12)

  • Lot #: 041817S5
  • Exp 10/15/2017
  • 052417S2
  • Exp 11/20/2017
  • 071117S4
  • Exp 1/7/2018
  • 0712217S4
  • Exp 1/8/2018
  • 080317S6
  • Exp 1/30/2018
  • 082217S5
  • Exp 2/1/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Banner Pharmacy Services, LLC 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 14 products in this recall →

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