Drug recall
ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
FDA recall event 88693 · Class II · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Key facts
| Event ID | 88693 |
|---|---|
| Recall numbers | D-0028-2022, D-0029-2022, D-0030-2022, D-0031-2022, D-0032-2022, D-0033-2022, D-0034-2022, D-0035-2022, D-0036-2022, D-0037-2022, D-0038-2022, D-0039-2022 and 28 more |
| Recalling firm | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
| Product type | Drugs |
| Products | ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx, ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx, ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx, ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx, ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx and 32 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns |
| Initiation date | Aug 13, 2021 |
| Report date | Nov 3, 2021 |
| Termination date | Apr 12, 2023 |
| City | Mesa |
| State | AZ |
| Country | United States |
| FEI number | 3015235235 |
At a glance
- 10–99 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: