The Recall Desk
SevereFDA (Drugs)·D-0756-2016·Announced 2016-03-16

Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns

Hartley Medical Center Pharmacy is recalling two syringes of Hydromorphone HCL 1 mg/ml because the agency could not ensure the product was sterile.

What this means for you

Illness, injury, or structural failure has been reported. 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 the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While no specific injuries are reported in the text, the lack of sterility assurance for an injectable drug represents a significant health risk consistent with the Severe classification for Class II recalls with potential for serious harm.

Plain-English summary

Hartley Medical Center Pharmacy, Incorporated is recalling two syringes of Hydromorphone HCL 1 mg/ml, 22 ml volume, prescription only. The recall was initiated due to a lack of assurance of sterility for the product.

The affected product has a best-use date of 5/3/2016. The recall is limited to the United States, with no foreign distribution reported.

Consumers and healthcare providers should stop using the recalled syringes and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Hydromorphone HCL 1 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Affected units
2

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 (1)

  • BUD: 5/3/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 30 recalled by Hartley Medical Center Pharmacy, Incorporated 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 30 products in this recall →