Drug product
Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 ML). Compounded by Tri-Coast Pharmacy
D-0273-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 99 vials
- Official record key
drug-enforcement:D-0273-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016A (05/06/2016), 06282016B (07/01/2016), 06212016A (06/24/2016), 06142016A (06/17/2016), 06072016E (06/10/2016), 06022016B (06/05/2016), 06022016A (06/05/2016), 07262016H (07/29/2016), 07192016A (07/22/2016), 07122016A (07/15/2016), 07082016D (07/11/2016), 07062016B (07/09/2016), 08302016B (09/03/2016), 08232016D (08/26/2016), 08162016D (08/19/2016), 08092016E (08/11/2016), 08042016F (08/07/2016), 09272016D (09/30/2016), 09272016B (09/30/2016), 09202016A (09/23/2016), 09132016A (09/16/2016), 09072016B (09/10/2016), 10112016D (10/14/2016), 10042016B (10/07/2016), 11022016A (11/05/2016), 11092016A (11/12/2016), 11082016A (11/11/2016)
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility