Drug recall: 5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding…
Class II FDA enforcement event 76912. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Key Pharmacy and Compounding Center started this drug recall on 18 Apr 2017. The firm address in the FDA record is in Federal Way, WA. FDA put the recall in Class II. FDA event 76912 has 79 product records. The first FDA enforcement report date is 24 May 2017. The record gives the status Terminated, with the termination date 29 Aug 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributed nationwide in U.S.A., Australia and Canada.
Recalling firm
Key Pharmacy and Compounding Center, Federal Way, WA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
79 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0707-2017 | 5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 100 vials | Class II | Terminated | 24 May 2017 |
| D-0708-2017 | 5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 6 vials | Class II | Terminated | 24 May 2017 |
| D-0709-2017 | 5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy | 3 vials | Class II | Terminated | 24 May 2017 |
| D-0710-2017 | 5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy | 63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial) | Class II | Terminated | 24 May 2017 |
| D-0711-2017 | ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy | 60 mL total | Class II | Terminated | 24 May 2017 |
| D-0712-2017 | ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial, Prepared by Key Compounding Pharmacy | 9 mL | Class II | Terminated | 24 May 2017 |
| D-0713-2017 | CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy | 1 vial | Class II | Terminated | 24 May 2017 |
| D-0714-2017 | DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy | 214 vials | Class II | Terminated | 24 May 2017 |
| D-0715-2017 | DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key Compounding Pharmacy | 10 mL total | Class II | Terminated | 24 May 2017 |
| D-0716-2017 | FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/mL, Rx only, 10 mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 1 vial | Class II | Terminated | 24 May 2017 |
| D-0717-2017 | FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy | 20 vials | Class II | Terminated | 24 May 2017 |
| D-0718-2017 | FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy | 3 vials total | Class II | Terminated | 24 May 2017 |
| D-0719-2017 | FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy | 12 vials total (3/2mL vials and 9/10mL vias) | Class II | Terminated | 24 May 2017 |
| D-0720-2017 | HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 72 vials | Class II | Terminated | 24 May 2017 |
| D-0721-2017 | HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy | 50 vials | Class II | Terminated | 24 May 2017 |
| D-0722-2017 | HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 2ML SDV 10MG/ML INJ, Injection, 10mg/mL, RX only, 2 mL glass/ Single Dose vial. | 50 vials total (10/1mL vials and 40/2mL vials) | Class II | Terminated | 24 May 2017 |
| D-0723-2017 | HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 240 mL | Class II | Terminated | 24 May 2017 |
| D-0724-2017 | HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial. | 8 vials total (6/10mL vials and 2/30 mL vials) | Class II | Terminated | 24 May 2017 |
| D-0725-2017 | HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy | 7 vials total (1/5mL vial and 6/30 mL vials) | Class II | Terminated | 24 May 2017 |
| D-0726-2017 | HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0727-2017 | HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5 mL and 30 mL Glass/ Multiple Dose vials, Prepared by Key Compounding Pharmacy | 27 vials total (25/5 mL vials and 2/30mL vials) | Class II | Terminated | 24 May 2017 |
| D-0728-2017 | HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 1 vial | Class II | Terminated | 24 May 2017 |
| D-0729-2017 | PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 4 vials | Class II | Terminated | 24 May 2017 |
| D-0730-2017 | PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 4 vials | Class II | Terminated | 24 May 2017 |
| D-0731-2017 | PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, and 15 mL Glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy | 5 vials total (2/5 mL vials, 1/10mL vial, and 2/15mL vials) | Class II | Terminated | 24 May 2017 |
| D-0732-2017 | PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0733-2017 | PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0734-2017 | PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0735-2017 | TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0736-2017 | TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/2.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy | 1 vial | Class II | Terminated | 24 May 2017 |
| D-0737-2017 | TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy | 200 vials | Class II | Terminated | 24 May 2017 |
| D-0738-2017 | TRI MIX 10/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/30mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy | 6 vials | Class II | Terminated | 24 May 2017 |
| D-0739-2017 | TRI MIX 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.59mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 1 vial | Class II | Terminated | 24 May 2017 |
| D-0740-2017 | TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, RX only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 1 vial | Class II | Terminated | 24 May 2017 |
| D-0741-2017 | TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ, Injection, 16.7mcg/4mg/0.27mg/ml, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 1 vial | Class II | Terminated | 24 May 2017 |
| D-0742-2017 | TRI MIX 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 25 vials | Class II | Terminated | 24 May 2017 |
| D-0743-2017 | TRI MIX 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0744-2017 | TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 3 vials | Class II | Terminated | 24 May 2017 |
| D-0745-2017 | TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ, Injection, 20mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial , Prepared by Key Compounding Pharmacy | 17 vials | Class II | Terminated | 24 May 2017 |
| D-0746-2017 | TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0747-2017 | TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0748-2017 | TRI MIX 40/30/4 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/4mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 5 vials | Class II | Terminated | 24 May 2017 |
| D-0749-2017 | TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ, Injection, 45.45mcg/27.27mg/0.45mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 1 vial | Class II | Terminated | 24 May 2017 |
| D-0750-2017 | TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection, 5.88mcg/17.65mg/0.588mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 3 vials | Class II | Terminated | 24 May 2017 |
| D-0751-2017 | TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 4 vials | Class II | Terminated | 24 May 2017 |
| D-0752-2017 | TRI MIX 5/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 5mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0753-2017 | TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0754-2017 | QUAD MIX 1/30/0.5/0.1 5ML MDV MCG/MG/MG/MG/ML INJ, Injection, 1mcg/30mg/0.5mg/0.15mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0755-2017 | QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30mg/1mg/0.2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 1 vial | Class II | Terminated | 24 May 2017 |
| D-0756-2017 | PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 3 vials | Class II | Terminated | 24 May 2017 |
| D-0757-2017 | PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 4 vials | Class II | Terminated | 24 May 2017 |
| D-0758-2017 | ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 1 vial | Class II | Terminated | 24 May 2017 |
| D-0759-2017 | VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, Prepared by Key Compounding Pharmacy | 10 mL | Class II | Terminated | 24 May 2017 |
| D-0760-2017 | CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 1 vial | Class II | Terminated | 24 May 2017 |
| D-0761-2017 | CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0763-2017 | FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy | 3 vials total (2/5mL vials and 1/10mL) | Class II | Terminated | 24 May 2017 |
| D-0764-2017 | IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx only, 5mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy | 2 vials | Class II | Terminated | 24 May 2017 |
| D-0765-2017 | GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 240 mL | Class II | Terminated | 24 May 2017 |
| D-0766-2017 | GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/Single Dose vial, Prepared by Key Compounding Pharmacy | 50 mL | Class II | Terminated | 24 May 2017 |
| D-0767-2017 | GSH/NAC INH PV 150/50MG/ML SOLN, Inhalation Solution, 150mg/50mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy | 180mL | Class II | Terminated | 24 May 2017 |
The table shows 60 of 79 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2017
- 343
- Share of these events in Class II
- 57%
- Product records in this event
- 79
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-0707-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 76912. https://recallregister.com/fda/ii/76912/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributed nationwide in U.S.A., Australia and Canada.
- What quantity of product is in FDA event 76912?
- The event has 79 product records. The first record gives this quantity:
100 vials
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2017 have the same class?
- 57% of the 343 drug events that started in 2017 are in Class II.