CLASS II Drug recall · Reported 2 May 2018 · FDA Enforcement Report
Hydromorphone HCl 1 mg/mL PF INJ recalled by Premier Pharmacy Labs
Premier Pharmacy Labs is recalling Hydromorphone HCl 1 mg/mL PF INJ, distributed nationwide in the US. The recall was initiated on 11 Apr 2018 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-0701-2018
- FDA event ID
- 79803
- Recalling firm
- Premier Pharmacy Labs, Weeki Wachee, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Apr 2018
- FDA classified
- 26 Apr 2018
- Reported
- 2 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 11 Apr 2018 | Recall initiated by company | |
| 26 Apr 2018 | Classified by FDA | +15 days |
| 2 May 2018 | 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:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
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 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Which lots are affected?
Lots: HYD030118IJDSA, HYD030118IJDSB, HYD030118IJDSD, HYD030118IJDSE BUD: 05/30/2018
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
3 other products · FDA event 79803This product is part of a recall event; the main page for the event is NEOstigmine Methylsulfate (1 mg/mL) 3mg per Single Dose Syringe recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | NEOstigmine Methylsulfate (1 mg/mL) 3mg per Single Dose Syringe recalled | Premier Pharmacy Labs | Sterility | Nationwide | |
| CLASS II | Morphine Sulfate 2 mg/mL PF Injection recalled by Premier Pharmacy Labs | Premier Pharmacy Labs | Sterility | Nationwide | |
| CLASS II | Morphine Sulfate 4 mg/mL PF Injection recalled by Premier Pharmacy Labs | Premier Pharmacy Labs | Sterility | Nationwide |
More recalls from Premier Pharmacy Labs
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naloxone HCL Preserved INJ, 500mg/ (10mg/mL) Sterile MDV recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Orphenadrine Citrate Sterile Injectable Solution *Contains recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Mitomycin Preservative Free Irrigation, 40mg/ (4mg/mL) SDV recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg recalled | Premier Pharmacy Labs | 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 |