Recall Enforment Report D-0019-2022

Drug Recall Enforcement Report Class II voluntary initiated by Piramal Critical Care, Inc., originally initiated on 09-10-2021 for the product 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 The product was recalled due to labeling: label lacks warning or rx legend: finished product did not include the statement on the flip cap vial, "warning: paralyzing agent". The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 88841 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0019-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
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" What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 100 glass vials Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 10-27-2021
Recall Initiation Date 09-10-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Piramal Critical Care, Inc.
Code Info Lot #: 20415001, 20415002, Expiration Date 05/2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status Ongoing