CLASS II Drug recall · Reported 15 Apr 2020 · FDA Enforcement Report
rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled
PharMEDium Services is recalling rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe, for IV Use, PharMEDium 13N, distributed nationwide in the US. The recall was initiated on 16 Mar 2020 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-1087-2020
- FDA event ID
- 85212
- Recalling firm
- PharMEDium Services, Dayton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Mar 2020
- FDA classified
- 6 Apr 2020
- Reported
- 15 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 16 Mar 2020 | Recall initiated by company | |
| 6 Apr 2020 | Classified by FDA | +21 days |
| 15 Apr 2020 | 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
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05
Where it was distributed
Distributed Nationwide in the US
Questions about this recall
Is rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe, for IV Use, PharMEDium 13N recalled?
Yes. PharMEDium Services recalled rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe, for IV Use, PharMEDium 13N on 16 Mar 2020. The recall is Class II and its status is Terminated. Recall number D-1087-2020.
Why was it recalled?
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Which lots are affected?
193500019D 3/16/2020 193510014D 3/17/2020 193520009D 3/18/2020
Where was it sold?
Distributed Nationwide in 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from PharMEDium Services
All 291| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 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 |
| Drug | CLASS II | ePHEDrine Sulfate, 5 mg per mL, 50 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |