Why it was recalled
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Product description
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
Lot numbers, UPCs & expiration codes
Lot #s: 09003, Exp 04/17/17; 11003, Exp 06/21/17; 11035, Exp 07/03/17; 11039, Exp 07/05/17; 12002, Exp 07/23/17; 12012, Exp 07/30/17.
Where it was sold
Nationwide in the USA and Puerto Rico
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-0685-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 6, 2017
- FDA report date
- May 3, 2017
- Quantity
- 851 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Isomeric Pharmacy Solution, LLC
Original FDA data
Every field from FDA enforcement report D-0685-2017, exactly as published.
Show all FDA fields
- City
- Salt Lake City
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 76951
- Address
- 2401 S Foothill Dr Ste D
- Code information
- Lot #s: 09003, Exp 04/17/17; 11003, Exp 06/21/17; 11035, Exp 07/03/17; 11039, Exp 07/05/17; 12002, Exp 07/23/17; 12012, Exp 07/30/17.
- Postal code
- 84109-1479
- Report date
- May 3, 2017
- Product type
- Drugs
- Recall number
- D-0685-2017
- Classification
- Class II
- Recalling firm
- Isomeric Pharmacy Solution, LLC
- Product quantity
- 851 vials
- Termination date
- Aug 30, 2017
- Reason for recall
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Apr 6, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 26, 2017