CLASS I Drug recall · Reported 27 Aug 2014 · FDA Enforcement Report
Ascorbic Acid 500 mg/mL Sterile Injection Multi-dose Vial recalled
Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL Sterile Injection Multi-dose Vial, distributed in New Jersey, New York, Puerto Rico. The recall was initiated on 25 Jun 2014 and the FDA has classified it as Class I.
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-1546-2014
- FDA event ID
- 68669
- Recalling firm
- Pharmacy Creations, Randolph, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 25 Jun 2014
- FDA classified
- 19 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Drug class
- Injectable & IV Drugs
Timeline
| 25 Jun 2014 | Recall initiated by company | |
| 19 Aug 2014 | Classified by FDA | +55 days |
| 27 Aug 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Product as listed by the FDA
Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.
Where it was distributed
NY, NJ, and Puerto Rico
Questions about this recall
Is Ascorbic Acid 500 mg/mL Sterile Injection Multi-dose Vial recalled?
Yes. Pharmacy Creations recalled Ascorbic Acid 500 mg/mL Sterile Injection Multi-dose Vial on 25 Jun 2014. The recall is Class I and its status is Terminated. Recall number D-1546-2014.
Why was it recalled?
Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Which lots are affected?
Lot: 06062014@8, Do Not Use Beyond 12/03/2014
Where was it sold?
NY, NJ, and Puerto Rico
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pharmacy Creations
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Magnesium Chloride 20% (200mg/mL) Sterile Injection Multi-Dose Vial recalled | Pharmacy Creations | Sterility | 4 states |
| Drug | CLASS I | Tropi/Cyclo/Phenyl/Tobra/Flurb recalled by Pharmacy Creations | Pharmacy Creations | Sterility | 4 states |
| Drug | CLASS I | Glutathione 100mg/mL Sterile Injection Multi Dose Vial recalled | Pharmacy Creations | Sterility | 4 states |
| Drug | CLASS I | Ascorbic Acid 500 mg/mL Sterile Injection Multi-dose Vial recalled | Pharmacy Creations | Sterility | 4 states |
| Drug | CLASS II | EDTA disodium 150 mg/mL Sterile Injection Multi Dose Vial recalled | Pharmacy Creations | Sterility | NJ |