The Recall Desk
SevereFDA (Drugs)·D-0753-2016·Announced 2016-03-16

Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns

Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 2 mg/ml syringes due to a lack of assurance of sterility.

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, which corresponds to a Severe severity score (4) according to the rubric, particularly given the risk of infection associated with non-sterile injectable drugs.

Plain-English summary

Hartley Medical Center Pharmacy, Incorporated is recalling Hydromorphone HCL 2 mg/ml, 20 ml syringes. The recall is being conducted because of a lack of assurance of sterility for the product.

The affected product is prescription-only and was distributed nationwide. No foreign distribution is reported. The specific product code information indicates a Beyond Use Date (BUD) of 5/3/2016.

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 2 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy Long Beach, CA
Affected units
1

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 →