Drug recall
Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ…
FDA recall event 69184 · Class I · Pharmacy Creations
Key facts
| Event ID | 69184 |
|---|---|
| Recall numbers | D-0305-2015, D-0306-2015, D-0307-2015, D-0308-2015 |
| Recalling firm | Pharmacy Creations |
| Product type | Drugs |
| Products | Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756., Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756., Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756., Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile. |
| Initiation date | Sep 5, 2014 |
| Report date | Dec 31, 2014 |
| Termination date | Jul 6, 2015 |
| City | Randolph |
| State | NJ |
| Country | United States |
| FEI number | 3003348498 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: