FDA-Drug2014-11-05Class II

Acetylcysteine 10% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.
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.

Sold states
Nationwide
Affected count
1440 mL
Manufactured in
1247 Rickert Dr, N/A, Naperville, IL, United States
Products
Acetylcysteine 10% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0054-2015

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