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Class II: temporary or reversible health riskTerminated

Unique Pharmaceutical NORepinephrine 4 mg in 250 mL Sodium Recall

NORepinephrine 4 mg in 250 mL Sodium Chloride0

Unique Pharmaceutical, Ltd · Temple, TX

Risk level
Class II
Reported by FDA
Sep 24, 2014
Recall ID
D-1587-2014
Check your lot numberHow we source this data

Summary

Unique Pharmaceutical recalled NORepinephrine 4 mg in 250 mL Sodium starting Apr 17, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1587-2014 on Sep 24, 2014. Reason: Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.

Product description

NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502

Lot numbers, UPCs & expiration codes

Lot # 00083844 Exp. 07/13

Where it was sold

TN, PA, and TX

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-1587-2014
Classification
Class II
Status
Terminated
Recall initiated
Apr 17, 2013
FDA report date
Sep 24, 2014
Quantity
430 Bags
Recall type
Voluntary: Firm initiated
Recalling firm
Unique Pharmaceutical, Ltd

Original FDA data

Every field from FDA enforcement report D-1587-2014, exactly as published.

Show all FDA fields
City
Temple
State
TX
Status
Terminated
Country
United States
Event ID
67904
Address
5920 S General Bruce Dr
Address (line 2)
Ste 100
Code information
Lot # 00083844 Exp. 07/13
Postal code
76502-5803
Report date
Sep 24, 2014
Product type
Drugs
Recall number
D-1587-2014
Classification
Class II
Recalling firm
Unique Pharmaceutical, Ltd
Product quantity
430 Bags
Termination date
Jan 26, 2016
Reason for recall
Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.
Voluntary / mandated
Voluntary: Firm initiated
Product description
NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502
Distribution pattern
TN, PA, and TX
Recall initiation date
Apr 17, 2013
Initial firm notification
Letter
Center classification date
Sep 16, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1587-2014, published Sep 24, 2014. View the source record (openFDA) · FDA enforcement reports

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

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