CLASS II Drug recall · Reported 27 Oct 2021 · FDA Enforcement Report
Rocuronium Bromide Injection 50mg/ Multi-Dose Vial recalled
Piramal Critical Care is recalling Rocuronium Bromide Injection 50mg/ Multi-Dose Vial, distributed nationwide in the US. The recall was initiated on 10 Sep 2021 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-0019-2022
- FDA event ID
- 88841
- Recalling firm
- Piramal Critical Care, Bethlehem, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Sep 2021
- FDA classified
- 20 Oct 2021
- Reported
- 27 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Sep 2021 | Recall initiated by company | |
| 20 Oct 2021 | Classified by FDA | +40 days |
| 27 Oct 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Product as listed by the FDA
Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Which lots are affected?
Lot #: 20415001, 20415002, Expiration Date 05/2022
Where was it sold?
Nationwide within 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.
More recalls from Piramal Critical Care
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe recalledGablofen | Piramal Critical Care | Potency & Assay | Nationwide |
| Drug | CLASS II | Sevoflurane, USP (Inhalation Anesthetic) recalledSevoflurane | Piramal Critical Care | Other | Nationwide |
Other Rocuronium recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rocuronium Bromide Injection, Preservative Free, 10 mg / mL recalledRocuronium Bromide | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | AZ, NM, UT |
| Drug | CLASS II | rocuronium, 50 mg/, (10 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium 50 mg/ (10 mg/mL) Syringes recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium, 50 mg /, (10 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | ROcuronium Bromide 50 mg/ ( 10 mg/mL) Syringe recalled | New England Life Care | Manufacturing (CGMP) Deviations | Nationwide |