CLASS II Drug recall · Reported 16 Dec 2015 · FDA Enforcement Report
Ascorbic Acid 500 MG/ML Inj., Qty: Vial recalled by RemedyRepack
RemedyRepack is recalling Ascorbic Acid 500 MG/ML 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
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-0514-2016
- 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
Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0431-16
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 # B0105052-100715, Exp 07/01/2017
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 72699This 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 |
|---|---|---|---|---|---|
| CLASS II | Bicillin L-A/mL Inj., Qty: Syringe recalled by RemedyRepack | RemedyRepack | Packaging Defects | Nationwide | |
| CLASS II | Vitamin B-Complex 100, Multi MG Inj, Qty: Vial recalled by RemedyRepack | RemedyRepack | Packaging Defects | Nationwide | |
| CLASS II | Novolin 70/30/mL Solu., Qty: 1 Vial recalled by RemedyRepack | RemedyRepack | Packaging Defects | Nationwide | |
| CLASS II | Rocuronium Bromide 50 MG/ INJ., Qty: Vial recalled by RemedyRepack | RemedyRepack | Packaging Defects | Nationwide | |
| CLASS II | Lorazepam 2 mg/mL Inj., Qty: Vial recalled by RemedyRepack | RemedyRepack | Packaging Defects | Nationwide | |
| 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 |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack | RemedyRePack | Manufacturing (CGMP) Deviations | FL, PA, VA |
| Drug | CLASS II | Clindamycin HCl, QTY recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Carvedilol, QTY: per Blister Pack ( blister cards) recalled | RemedyRepack | Nitrosamine Impurity | FL |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled | RemedyRepack | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Potassium Chloride Micro 10mEq recalled by RemedyRepack | RemedyRepack | Potency & Assay | Nationwide |
Other Ascorbic Acid recalls
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ascorbic Acid 500mg/mL, a)-vial, b)-vial, Refrigerate recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Ascorbic Acid Solution for Injection recalled by Asp Cares | ASP Cares | Sterility | TX |
| Drug | CLASS II | Ascorbic Acid Sterile Injection Solution, 500 mg/mL vial recalled | Atlas Pharmaceuticals | Other | AZ, CO |
| Drug | CLASS II | Ascorbic Acid 500 MG/ML (Non-Corn) Injection (PFV) per vial recalled | RXQ Compounding | Other | Nationwide |
| Drug | CLASS II | Ascorbic Acid 400 MG/ML (Non-Corn) Injection Solution recalled | RXQ Compounding | Other | Nationwide |