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Class II: temporary or reversible health riskTerminated

Pharmedium Services 0.4 mcg/mL Sufentanil Citrate and 0.1% Recall

0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodi…

Pharmedium Services, LLC · Lake Forest, IL

Risk level
Class II
Reported by FDA
Jul 27, 2016
Recall ID
D-1370-2016
Check your lot numberHow we source this data

Summary

Pharmedium Services recalled 0.4 mcg/mL Sufentanil Citrate and 0.1% starting May 5, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1370-2016 on Jul 27, 2016. Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Status: Terminated.

Why it was recalled

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Product description

0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50

Lot numbers, UPCs & expiration codes

Lot Number 161080149M; Exp. Date 5/18/2016

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-1370-2016
Classification
Class II
Status
Terminated
Recall initiated
May 5, 2016
FDA report date
Jul 27, 2016
Quantity
10 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Pharmedium Services, LLC

Original FDA data

Every field from FDA enforcement report D-1370-2016, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
74057
Address
150 N Field Dr Ste 350
Code information
Lot Number 161080149M; Exp. Date 5/18/2016
Postal code
60045-2506
Report date
Jul 27, 2016
Product type
Drugs
Recall number
D-1370-2016
Classification
Class II
Recalling firm
Pharmedium Services, LLC
Product quantity
10 bags
Termination date
Mar 6, 2018
Reason for recall
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50
Distribution pattern
Nationwide
Recall initiation date
May 5, 2016
Initial firm notification
E-Mail
Center classification date
Jul 16, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1370-2016, published Jul 27, 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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