Recalls / Class II

Class IID-0273-2017

Product

Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 ML). Compounded by Tri-Coast Pharmacy

Affected lot / code info

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)

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Tri-Coast Pharmacy

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

14125 US Highway 1, N/A, Juno Beach, Florida 33408-1425

Distribution

Quantity

99 vials

Distribution pattern

Nationwide

Timeline

Recall initiated

2016-11-17

FDA classified

2017-01-04

Posted by FDA

2017-01-11

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0273-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.