Recalls / Class II

Class IID-0272-2017

Product

Methylcobalamin 1,000 mcg/mL, 10 mL and 30 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): 05312016KK, 05262016A (11/22/2016), 060920161 (12/06/2016), 07262016B (01/22/2017), 07062016C (12/31/2016), 08292016B (02/25/2017), 10132016F (04/11/2017), 10252016K (02/28/2017), 07262016C (01/22/2017), 09152016 (02/28/2017)

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

1,458 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-0272-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.