The Recall Desk
SevereFDA (Drugs)·D-0739-2016·Announced 2016-03-16

Hartley Medical Center Recalls Morphine and Baclofen Syringes for Sterility Concerns

Hartley Medical Center Pharmacy is recalling Morphine Sulfate and Baclofen syringes due to a lack of assurance of sterility. The affected products were distributed nationwide.

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 involves a lack of assurance of sterility in a prescription medication, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Hartley Medical Center Pharmacy, Incorporated is recalling Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml, 20 ml syringes. The recall is being conducted because of a lack of assurance of sterility. The affected products are prescription-only medications manufactured by Hartley Medical Center Pharmacy in Long Beach, California.

The recall covers products with a best-use date of May 3, 2016. The distribution pattern for these syringes was nationwide, with no foreign distribution reported. The agency has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected syringes and contact their pharmacist or the recalling firm for further instructions. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/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 →