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Class II: temporary or reversible health riskTerminated

PharMedium Services Potassium PHOSphate in 0 Recall

Potassium PHOSphate in 0

PharMedium Services, Llc · Sugar Land, TX

Risk level
Class II
Reported by FDA
Jul 26, 2017
Recall ID
D-0990-2017
Check your lot numberHow we source this data

Summary

PharMedium Services recalled Potassium PHOSphate in 0 starting Jun 26, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0990-2017 on Jul 26, 2017. Reason: Lack of Assurance of Sterility; media fill failure at manufacturer. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; media fill failure at manufacturer

Product description

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11

Lot numbers, UPCs & expiration codes

Lots: 171220007S Exp. 7/31/2017, 171280129S Exp. 8/7/2017, 171320112S Exp. 8/13/2017, 171590010S Exp. 9/7/2017

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-0990-2017
Classification
Class II
Status
Terminated
Recall initiated
Jun 26, 2017
FDA report date
Jul 26, 2017
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
PharMedium Services, Llc

Original FDA data

Every field from FDA enforcement report D-0990-2017, exactly as published.

Show all FDA fields
City
Sugar Land
State
TX
Status
Terminated
Country
United States
Event ID
77634
Address
12620 W Airport Blvd Ste 130
Code information
Lots: 171220007S Exp. 7/31/2017, 171280129S Exp. 8/7/2017, 171320112S Exp. 8/13/2017, 171590010S Exp. 9/7/2017
Postal code
77478-6200
Report date
Jul 26, 2017
Product type
Drugs
Recall number
D-0990-2017
Classification
Class II
Recalling firm
PharMedium Services, Llc
Termination date
Apr 29, 2020
Reason for recall
Lack of Assurance of Sterility; media fill failure at manufacturer
Voluntary / mandated
Voluntary: Firm initiated
Product description
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5301 NDC# 61553-301-11
Distribution pattern
Nationwide
Recall initiation date
Jun 26, 2017
Initial firm notification
Press Release
Center classification date
Jul 14, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0990-2017, published Jul 26, 2017. 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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