Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns
Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 25 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. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in injectable drugs) map to a score of 4 (Severe), as Class I is required for a score of 5.
Plain-English summary
Hartley Medical Center Pharmacy, Incorporated is recalling Hydromorphone HCL 25 mg/ml, 40 ml syringes. The recall was initiated because of a lack of assurance of sterility for the product.
The affected product is a prescription-only medication manufactured by Hartley Medical Center Pharmacy, Incorporated, located in Long Beach, California. The specific lot identified has a beyond-use date of May 3, 2016. The product was distributed nationwide, with no foreign distribution reported.
Consumers and healthcare providers should stop using the recalled syringes and contact their pharmacist or the recalling firm for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, 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.
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