Exact FDA event identifier

Event 88841

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: September 10, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Piramal Critical Care, Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0019-2022

Recall number: D-0019-2022
Initiated: September 10, 2021
Classification: Class II
Status: Terminated
Recalling firm: Piramal Critical Care, Inc.
Quantity: 100 glass vials

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Label Lacks Warning or Rx Legend: Finished product did not include

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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"

Code information

Lot #: 20415001, 20415002, Expiration Date 05/2022

Distribution pattern

Nationwide within the United States