RecallRadar

FDA Drug recall D-0068-2018

ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Lit…

On 2017-11-08 the FDA classified a Class II recall of ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Lit… by Sca Pharmaceuticals, citing lack Of Assurance Of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0068-2018
ClassificationClass II
Statusterminated
Initiated2017-10-19
Published2017-11-08
Last updated2026-09-13 11:51 UTC
CompanySca Pharmaceuticals
DistributionUS

Product

ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09

Reason

Lack Of Assurance Of Sterility.

Identifiers

code_infoLot: 20171004@4 BUD: 01/09/2018

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0068-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.