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Class II: temporary or reversible health riskTerminated

Pharmedium Services Oxytocin 10 units added to 500 mL Lactated Recall

Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Onl…

Pharmedium Services, LLC · Lake Forest, IL

Risk level
Class II
Reported by FDA
Nov 1, 2017
Recall ID
D-0036-2018
Check your lot numberHow we source this data

Summary

Pharmedium Services recalled Oxytocin 10 units added to 500 mL Lactated starting Sep 1, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0036-2018 on Nov 1, 2017. Reason: Subpotent Drug. Status: Terminated.

Why it was recalled

Subpotent Drug

Product description

Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-01

Lot numbers, UPCs & expiration codes

All unexpired lots.

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-0036-2018
Classification
Class II
Status
Terminated
Recall initiated
Sep 1, 2017
FDA report date
Nov 1, 2017
Quantity
1308 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Pharmedium Services, LLC

Original FDA data

Every field from FDA enforcement report D-0036-2018, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
78063
Address
150 N Field Dr Ste 350
Code information
All unexpired lots.
Postal code
60045-2506
Report date
Nov 1, 2017
Product type
Drugs
Recall number
D-0036-2018
Classification
Class II
Recalling firm
Pharmedium Services, LLC
Product quantity
1308 bags
Termination date
Jan 24, 2020
Reason for recall
Subpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-01
Distribution pattern
Nationwide.
Recall initiation date
Sep 1, 2017
Initial firm notification
Press Release
Center classification date
Oct 25, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0036-2018, published Nov 1, 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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