CLASS II Drug recall · Reported 1 Nov 2017 · FDA Enforcement Report
Hydromorphone HCl 10 mg (0.2mg/ml) syringes in 0.9% Sodium Chloride recalled
Banner Pharmacy Services is recalling Hydromorphone HCl 10 mg (0.2mg/ml) syringes in 0.9% Sodium Chloride, distributed nationwide in the US. The recall was initiated on 10 Oct 2017 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-0019-2018
- FDA event ID
- 78227
- Recalling firm
- Banner Pharmacy Services, Chandler, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2017
- FDA classified
- 23 Oct 2017
- Reported
- 1 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 10 Oct 2017 | Recall initiated by company | |
| 23 Oct 2017 | Classified by FDA | +13 days |
| 1 Nov 2017 | Published in enforcement report | +9 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.
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 HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001.
Where it was distributed
Nationwide within the US
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility.
Which lots are affected?
Lot #: 041817S5, Exp 10/15/2017; 052417S2, Exp 11/20/2017; 071117S4, Exp 1/7/2018; 0712217S4, Exp 1/8/2018; 080317S6, Exp 1/30/2018; 082217S5, Exp 2/1/2018
Where was it sold?
Nationwide within the US
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
13 other products · FDA event 78227More recalls from Banner Pharmacy Services
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Succinylcholine 200 mg/ Syringe recalled by Banner Pharmacy Services | Banner Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | fentanyl citrate (PF) 1100 mcg (20 mcg/mL) syringes recalled | Banner Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Midazolam HCL 100 mg (1mg/mL) Cassette in 0.9% Sodium Chloride recalled | Banner Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Ropivacaine HCL (PF) 0.2% (2mg/mL) Cassette recalled | Banner Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | VANCOmycin added to 0.9% Sodium Chloride recalled | Banner Pharmacy Services | Sterility | Nationwide |
Other 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 |