CLASS II Drug recall · Reported 16 Dec 2015 · FDA Enforcement Report

Rocuronium Bromide 50 MG/ INJ., Qty: Vial recalled by RemedyRepack

RemedyRepack is recalling Rocuronium Bromide 50 MG/ INJ., Qty: Vial, distributed nationwide in the US. The recall was initiated on 11 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot#: B0073852-030915, Exp 04/2016

Quantity recalled4 Vials

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-0517-2016
FDA event ID: 72699
Recalling firm: RemedyRepack, Indiana, PA
Classification: Class II
Status: Terminated
Recall initiated: 11 Nov 2015
FDA classified: 4 Dec 2015
Reported: 16 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Injectable & IV Drugs

Timeline

11 Nov 2015	Recall initiated by company
4 Dec 2015	Classified by FDA	+23 days
16 Dec 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0222-57

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.

Which lots are affected?

Lot#: B0073852-030915, Exp 04/2016

Where was it sold?

Nationwide

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.

Other products in this recall event

6 other products · FDA event 72699

This product is part of a recall event; the main page for the event is Bicillin L-A/mL Inj., Qty: Syringe recalled by RemedyRepack.

Reported	Class	Recall	Company	Reason	Where
16 Dec 2015	CLASS II	Bicillin L-A/mL Inj., Qty: Syringe recalled by RemedyRepack	RemedyRepack	Packaging Defects	Nationwide
16 Dec 2015	CLASS II	Vitamin B-Complex 100, Multi MG Inj, Qty: Vial recalled by RemedyRepack	RemedyRepack	Packaging Defects	Nationwide
16 Dec 2015	CLASS II	Ascorbic Acid 500 MG/ML Inj., Qty: Vial recalled by RemedyRepack	RemedyRepack	Packaging Defects	Nationwide
16 Dec 2015	CLASS II	Novolin 70/30/mL Solu., Qty: 1 Vial recalled by RemedyRepack	RemedyRepack	Packaging Defects	Nationwide
16 Dec 2015	CLASS II	Lorazepam 2 mg/mL Inj., Qty: Vial recalled by RemedyRepack	RemedyRepack	Packaging Defects	Nationwide
16 Dec 2015	CLASS II	Humulin 70/30/mL Inj, Qty: Vial recalled by RemedyRepack	RemedyRepack	Packaging Defects	Nationwide

More recalls from RemedyRepack

All 61

Reported	Class	Recall	Company	Reason	Where
14 May 2025Drug	CLASS II	Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack	RemedyRePack	Manufacturing (CGMP) Deviations	FL, PA, VA
30 Apr 2025Drug	CLASS II	Clindamycin HCl, QTY recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	PA
12 Feb 2025Drug	CLASS II	Carvedilol, QTY: per Blister Pack ( blister cards) recalled	RemedyRepack	Nitrosamine Impurity	FL
1 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled	RemedyRepack	Nitrosamine Impurity	Nationwide
24 Jul 2024Drug	CLASS II	Potassium Chloride Micro 10mEq recalled by RemedyRepack	RemedyRepack	Potency & Assay	Nationwide

Other Rocuronium recalls

All 17

Reported	Class	Recall	Company	Reason	Where
20 Mar 2024Drug	CLASS II	Rocuronium Bromide Injection, Preservative Free, 10 mg / mL recalledRocuronium Bromide	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	AZ, NM, UT
11 Oct 2023Drug	CLASS II	rocuronium, 50 mg/, (10 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023Drug	CLASS II	rocuronium 50 mg/ (10 mg/mL) Syringes recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	rocuronium, 50 mg /, (10 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
26 Jul 2023Drug	CLASS II	ROcuronium Bromide 50 mg/ ( 10 mg/mL) Syringe recalled	New England Life Care	Manufacturing (CGMP) Deviations	Nationwide