FDA Drug Recalls

Recalls / Class II

Class IID-1161-2019

Product

Methionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine 10 mg, benzyl alcohol/ water, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

Affected lot / code info
All Lots

Why it was recalled

Lack of sterility assurance.

Recalling firm

Firm
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
Attn: Cleve Anderson, 310 Bluff City Hwy, Bristol, Tennessee 37620-4602

Distribution

Quantity
276 vails
Distribution pattern
Nationwide

Timeline

Recall initiated
2019-04-02
FDA classified
2019-04-18
Posted by FDA
2019-04-24
Terminated
2021-09-24
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1161-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.