Hartley Medical Center Pharmacy Recalls Morphine Sulfate Combination Vials
Hartley Medical Center Pharmacy is recalling Morphine Sulfate, Sufentanil Citrate, and Bupivacaine HCL vials due to a lack of assurance of sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a medication, which poses a risk of harm even without reported injuries.
Plain-English summary
Hartley Medical Center Pharmacy, Incorporated is recalling Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, 20 ml vials. The recall is being conducted because of a lack of assurance of sterility.
The affected product is a prescription-only medication distributed nationwide. The specific lot information provided indicates a Beyond Use Date (BUD) of 5/3/2016. No foreign distribution is reported.
Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, vol. 20 ml vial, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
- Manufacturer
- Hartley Medical Center Pharmacy, Incorporated
- Category
- Drug — Injectable Medication
- 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.
See all 30 products in this recall →Related recalls
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