US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 25, 2012 (14 years ago)

Hydrochloric Acid Injection 2mg/Ml Injectable 400 Ml

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

What was recalled

HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PRODUCTS)

Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1538-2012

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Hydrochloric recalls

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Class II · Moderate risk Terminated

S-Hydrochloric Acid 2mg/Ml Inj Soln

Reason Lack of Assurance of Sterility

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0228-2020
Class II · Moderate risk Terminated

LIPO B STERILE INJECTION 10 mL

Reason Subpotent Drug: trace amounts of methylcobalamin in compounded drug.

Eagle Pharmacy, Inc. D-1832-2015
Class II · Moderate risk Terminated

Hydrochloric acid/water for injection 10%

Reason 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.

Martin Avenue Pharmacy, Inc. D-0087-2015