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Class II: temporary or reversible health riskTerminated

Cantrell Drug HYDROmorphone HCl 6 mg/30 mL in 0 Recall

HYDROmorphone HCl 6 mg/30 mL in 0

Cantrell Drug Company · Little Rock, AR

Risk level
Class II
Reported by FDA
Dec 21, 2016
Recall ID
D-0194-2017
Check your lot numberHow we source this data

Summary

Cantrell Drug recalled HYDROmorphone HCl 6 mg/30 mL in 0 starting Nov 18, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0194-2017 on Dec 21, 2016. Reason: Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Product description

HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-002-03

Lot numbers, UPCs & expiration codes

Lot: 8742

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-0194-2017
Classification
Class II
Status
Terminated
Recall initiated
Nov 18, 2016
FDA report date
Dec 21, 2016
Quantity
2509 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Cantrell Drug Company

Original FDA data

Every field from FDA enforcement report D-0194-2017, exactly as published.

Show all FDA fields
City
Little Rock
State
AR
Status
Terminated
Country
United States
Event ID
75745
Address
7321 Cantrell Rd
Code information
Lot: 8742
Postal code
72207-4144
Report date
Dec 21, 2016
Product type
Drugs
Recall number
D-0194-2017
Classification
Class II
Recalling firm
Cantrell Drug Company
Product quantity
2509 syringes
Termination date
Apr 29, 2020
Reason for recall
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Voluntary / mandated
Voluntary: Firm initiated
Product description
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-002-03
Distribution pattern
Nationwide
Recall initiation date
Nov 18, 2016
Initial firm notification
Press Release
Center classification date
Dec 13, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0194-2017, published Dec 21, 2016. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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