Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns
Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 0.5 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential hospitalization risks or significant injury reports associated with sterility failures.
Plain-English summary
Hartley Medical Center Pharmacy, Incorporated is recalling Hydromorphone HCL 0.5 mg/ml, 20 ml syringes. The recall was initiated because of a lack of assurance of sterility for the product.
The affected product is prescription-only and was distributed nationwide. No foreign distribution occurred. The specific product code is identified by a Beyond Use Date (BUD) of 5/3/2016.
Consumers and healthcare providers should stop using the affected syringes and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
- Manufacturer
- Hartley Medical Center Pharmacy, Incorporated
- Category
- Drug — Injectable Medication
- 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
Same manufacturer · Hartley Medical Center Pharmacy, Incorporated
See all →- SevereHartley Medical Center Pharmacy Recalls Sufentanil Citrate Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-03-16
- SevereHartley Medical Center Pharmacy Recalls Baclofen Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-03-16
- SevereHartley Medical Center Pharmacy Recalls Baclofen Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-03-16
- SevereMorphine Sulfate Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2016-03-16
- SevereHartley Medical Center Pharmacy Recalls Morphine and Bupivacaine Syringes
FDA (Drugs) · 2016-03-16
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereFDA Recalls Hydromorphone Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-11-01
- SevereSCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-11-08
- HighHYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
- SevereCantrell Drug Recalls Hydromorphone Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-12-21
- HighHYDROmorphone Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-03
- HighFDA Recalls HYDROmorphone Syringes for Sterility Assurance Issue
FDA (Drugs) · 2023-10-11