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Class II: temporary or reversible health riskTerminated

Cantrell Drug MIDAZOLAM HCl in 0 Recall

MIDAZOLAM HCl in 0

Cantrell Drug Company · Little Rock, AR

Risk level
Class II
Reported by FDA
Jul 13, 2016
Recall ID
D-1164-2016
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Summary

Cantrell Drug recalled MIDAZOLAM HCl in 0 starting Aug 21, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1164-2016 on Jul 13, 2016. Reason: Subpotent Drug. Status: Terminated.

Why it was recalled

Subpotent Drug

Product description

MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161

Lot numbers, UPCs & expiration codes

Lot: 6178, exp, 9/12/15; 6529, exp 11/22/15

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1164-2016
Classification
Class II
Status
Terminated
Recall initiated
Aug 21, 2015
FDA report date
Jul 13, 2016
Quantity
1570 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Cantrell Drug Company

Original FDA data

Every field from FDA enforcement report D-1164-2016, exactly as published.

Show all FDA fields
City
Little Rock
State
AR
Status
Terminated
Country
United States
Event ID
72028
Address
7321 Cantrell Rd
Code information
Lot: 6178, exp, 9/12/15; 6529, exp 11/22/15
Postal code
72207-4144
Report date
Jul 13, 2016
Product type
Drugs
Recall number
D-1164-2016
Classification
Class II
Recalling firm
Cantrell Drug Company
Product quantity
1570 syringes
Termination date
Feb 3, 2017
Reason for recall
Subpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161
Distribution pattern
Nationwide
Recall initiation date
Aug 21, 2015
Initial firm notification
E-Mail
Center classification date
Jul 6, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1164-2016, published Jul 13, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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