CLASS II Drug recall · Reported 9 Aug 2023 · FDA Enforcement Report
HYDROmorphone in 0.9% sodium chloride, 15 mg/, (0.5 mg/mL) Syringe recalled
Central Admixture Pharmacy Services is recalling HYDROmorphone in 0.9% sodium chloride, 15 mg/, (0.5 mg/mL) Syringe, distributed nationwide in the US. The recall was initiated on 17 Jul 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1058-2023
- FDA event ID
- 92752
- Recalling firm
- Central Admixture Pharmacy Services, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2023
- FDA classified
- 3 Aug 2023
- Reported
- 9 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 17 Jul 2023 | Recall initiated by company | |
| 3 Aug 2023 | Classified by FDA | +17 days |
| 9 Aug 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of sterility: Lack of validation data for sanitization cycles
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Which lots are affected?
Lot: 17-270770, Exp. 7/19/2023; 17-271061, Exp. 7/24/2023; 17-271419, Exp. 7/30/2023; 17-271678, Exp. 8/2/2023; 17-272124, Exp. 8/10/2023; 17-272302, Exp. 8/14/2023; 17-272518, Exp. 8/17/2023; 17-273493, Exp. 9/4/2023; 17-273671, Exp. 9/6/2023.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
38 other products · FDA event 92752More recalls from Central Admixture Pharmacy Services
All 347Other Hydromorphone recalls
All 155| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | HYDROmorphone Hydrochloride 50mg/ (1mg/mL) recalled by OurPharma | OurPharma | Potency & Assay | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 30 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 25 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 20 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |