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.
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 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
- Manufacturer
- Hartley Medical Center Pharmacy, Incorporated
- Category
- Drug — Prescription Syringe
- 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 →Related recalls
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