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

Diazepam

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

DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML, 20 ML, 300 ML; DIAZEPAM 2.5MG/ML INJECTABLE 40 ML; DIAZEPAM 2MG/ML INJECTABLE 100 ML, 50 ML (8 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-1501-2012

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 Diazepam recalls

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Class II · Moderate risk Terminated

Diazepam Oral Solution

Reason Failed Impurities/Degradation Specifications: Out of specification results for related substances.

Lannett Company, Inc. NDC 0527-1768-36 D-0558-2022
Class III · Low risk Terminated

Diazepam Rectal Gel

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.

Valeant Pharmaceuticals North America LLC NDC 68682-650-20 D-1041-2018
Class II · Moderate risk Terminated

Diazepam Injection USP 10mg/2mL

Reason Crystallization: Product contains particulate identified to be crystallized active ingredient.

Hospira Inc. NDC 0409-1273-32 D-1359-2016
Class II · Moderate risk Terminated

Diazepam 5 mg/mL injectable packaged in an amber glass injectable vial

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-0078-2015