CLASS II Drug recall · Reported 15 Aug 2018 · FDA Enforcement Report
10 mg/mL Rocuronium Bromide (Preservative Free) BD Syringe recalled
PharMEDium Services is recalling 10 mg/mL Rocuronium Bromide (Preservative Free) BD Syringe, PharMEDium Services, LLC, distributed nationwide in the US. The recall was initiated on 24 Jul 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-1045-2018
- FDA event ID
- 80638
- Recalling firm
- PharMEDium Services, Dayton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2018
- FDA classified
- 3 Aug 2018
- Reported
- 15 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 24 Jul 2018 | Recall initiated by company | |
| 3 Aug 2018 | Classified by FDA | +10 days |
| 15 Aug 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Product as listed by the FDA
10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
Where it was distributed
Product was distributed throughout the United States
Questions about this recall
Why was it recalled?
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Which lots are affected?
Lot 181780003D
Where was it sold?
Product was distributed throughout the United States
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
2 other products · FDA event 80638| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 5 mg/mL Ephedrine Sulfate (Preservative Free) recalled | PharMEDium Services | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | 10 mcg/mL Fentanyl Citrate (Preservative Free) recalled | PharMEDium Services | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from PharMEDium Services
All 291| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |