Hartley Medical Center Pharmacy Recalls Morphine Sulfate Syringes for Sterility Concerns
Hartley Medical Center Pharmacy is recalling Morphine Sulfate 11 mg/ml syringes due to a lack of assurance of sterility. The product was 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. Per the rubric, FDA Class II recalls with potential for serious injury (such as sterility issues in injectable drugs) are classified as Severe.
Plain-English summary
Hartley Medical Center Pharmacy, Incorporated is recalling Morphine Sulfate 11 mg/ml, 20 ml syringes. The recall is being conducted because of a lack of assurance of sterility. The product is prescription-only and was distributed nationwide, with no foreign distribution.
The affected product has a beyond-use date of 5/3/2016. The recall is classified as Class II by the FDA. No specific lot numbers or quantities are provided in the source text.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacy or healthcare provider for further instructions.
The recalled product
- Product
- Morphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
- Manufacturer
- Hartley Medical Center Pharmacy, Incorporated
- Category
- Drug — Injectable
- Hazard
- 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.
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