Why it was recalled
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # t12-05-2016@116, Exp 6/4/2017; t12-15-2016@84, Exp 6/14/2017; t12-23-2016@67, Exp 6/25/2017; t12-28-2016@105, Exp 6/27/2017; t01-30-2017@88, Exp 7/30/2017; t02-06-2017@109, Exp 8/6/2017; t02-14-2017@92, Exp 8/14/2017; t02-20-2017@79, Exp 8/20/2017
Where it was sold
Distributed nationwide in U.S.A., Australia and Canada.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0710-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 18, 2017
- FDA report date
- May 24, 2017
- Quantity
- 63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Key Pharmacy and Compounding Center
Original FDA data
Every field from FDA enforcement report D-0710-2017, exactly as published.
Show all FDA fields
- City
- Federal Way
- State
- WA
- Status
- Terminated
- Country
- United States
- Event ID
- 76912
- Address
- 530 S 336th St
- Code information
- Lot # t12-05-2016@116, Exp 6/4/2017; t12-15-2016@84, Exp 6/14/2017; t12-23-2016@67, Exp 6/25/2017; t12-28-2016@105, Exp 6/27/2017; t01-30-2017@88, Exp 7/30/2017; t02-06-2017@109, Exp 8/6/2017; t02-14-2017@92, Exp 8/14/2017; t02-20-2017@79, Exp 8/20/2017
- Postal code
- 98003-6383
- Report date
- May 24, 2017
- Product type
- Drugs
- Recall number
- D-0710-2017
- Classification
- Class II
- Recalling firm
- Key Pharmacy and Compounding Center
- Product quantity
- 63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial)
- Termination date
- Aug 29, 2017
- Reason for recall
- Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed nationwide in U.S.A., Australia and Canada.
- Recall initiation date
- Apr 18, 2017
- Initial firm notification
- Letter
- Center classification date
- May 17, 2017