FDA Drug Class II — Moderate

Sodium tetradecyl sulfate 5% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Hazard

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Products

Sodium tetradecyl sulfate 5% (PF) injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Brand
Martin Avenue Pharmacy, Inc.
UPC
Lot Number: 08062014@32, Exp 9/5/2014; 08072014@62, Exp 9/6/2014

Units Affected

270 mL