Why it was recalled
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 20415001, 20415002, Expiration Date 05/2022
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0019-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 10, 2021
- FDA report date
- Oct 27, 2021
- Quantity
- 100 glass vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Piramal Critical Care, Inc.
Original FDA data
Every field from FDA enforcement report D-0019-2022, exactly as published.
Show all FDA fields
- City
- Bethlehem
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 88841
- Address
- 3950 Schelden Cir
- Code information
- Lot #: 20415001, 20415002, Expiration Date 05/2022
- Postal code
- 18017-8936
- Report date
- Oct 27, 2021
- Product type
- Drugs
- Recall number
- D-0019-2022
- Classification
- Class II
- Recalling firm
- Piramal Critical Care, Inc.
- Product quantity
- 100 glass vials
- Termination date
- Sep 7, 2022
- 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"
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 10, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 20, 2021