CLASS II Drug recall · Reported 24 May 2017 · FDA Enforcement Report
5-Mthf Sdv (Calif) 5MG/ML Inj, Injection 5mg/mL recalled
Key Pharmacy and Compounding Center is recalling 5-Mthf Sdv (Calif) 5MG/ML Inj, Injection 5mg/mL, distributed nationwide in the US. The recall was initiated on 18 Apr 2017 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-0709-2017
- FDA event ID
- 76912
- Recalling firm
- Key Pharmacy and Compounding Center, Federal Way, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Apr 2017
- FDA classified
- 17 May 2017
- Reported
- 24 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Apr 2017 | Recall initiated by company | |
| 17 May 2017 | Classified by FDA | +29 days |
| 24 May 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy
Where it was distributed
Distributed nationwide in U.S.A., Australia and Canada.
Questions about this recall
Is 5-Mthf Sdv (Calif) 5MG/ML Inj, Injection 5mg/mL recalled?
Yes. Key Pharmacy and Compounding Center recalled 5-Mthf Sdv (Calif) 5MG/ML Inj, Injection 5mg/mL on 18 Apr 2017. The recall is Class II and its status is Terminated. Recall number D-0709-2017.
Why was it recalled?
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Which lots are affected?
Lot # t12-28-2016@113, Exp 6/27/2017.
Where was it sold?
Distributed nationwide in U.S.A., Australia and Canada.
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 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 Key Pharmacy and Compounding Center
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Chloride Inh PF GV 9% Soln, Inhalation Solution recalled | Key Pharmacy and Compounding Center | Foreign Material | Nationwide |
| Drug | CLASS II | VIT C/GSH 25%-1.25% Ophth, Ophthalmic recalled | Key Pharmacy and Compounding Center | Foreign Material | Nationwide |
| Drug | CLASS II | PGE1 MDV INJ, Injection, 40mcg/mL recalled | Key Pharmacy and Compounding Center | Foreign Material | Nationwide |
| Drug | CLASS II | TRI MIX 6/18/0.6 MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL recalled | Key Pharmacy and Compounding Center | Foreign Material | Nationwide |
| Drug | CLASS II | Co-q-10 Oil Mdv (Calif) 25MG/ML Inj, Injection, 25mg/mL recalled | Key Pharmacy and Compounding Center | Foreign Material | Nationwide |