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Class II: temporary or reversible health riskTerminated

Pharmedium Services 0.0625% Bupivacaine HCl Recall

0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira…

Pharmedium Services, LLC · Lake Forest, IL

Risk level
Class II
Reported by FDA
Jul 27, 2016
Recall ID
D-1362-2016
Check your lot numberHow we source this data

Summary

Pharmedium Services recalled 0.0625% Bupivacaine HCl starting May 5, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1362-2016 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

0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL White Smiths Medical Cassette (NDC 615530-933-11) f) 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ;

Lot numbers, UPCs & expiration codes

Service Code 2H8197 , Lot Number 160730048M , Exp. Date 6/12/2016 ; Service Code 2H8197 , Lot Number 160840111M , Exp. Date 6/22/2016 ; Service Code 2H8197 , Lot Number 160870066M , Exp. Date 6/25/2016 ; Service Code 2H8197 , Lot Number 160880208M , Exp. Date 6/27/2016 ; Service Code 2H8197 , Lot Number 160910038M , Exp. Date 6/29/2016 ; Service Code 2K8189 , Lot Number 160730049M , Exp. Date 6/11/2016 ; Service Code 2K8189 , Lot Number 160810152M , Exp. Date 6/20/2016 ; Service Code 2K8189 , Lot Number 160820330M , Exp. Date 6/21/2016 ; Service Code 2K8189 , Lot Number 160940135M , Exp. Date 7/3/2016 ; Service Code 2K8189 , Lot Number 160960178M , Exp. Date 7/5/2016 ; Service Code 2K8189 , Lot Number 160970201M , Exp. Date 7/6/2016 ; Service Code 2K8197 , Lot Number 160660178M , Exp. Date 6/5/2016 ; Service Code 2K8197 , Lot Number 160670161M , Exp. Date 6/6/2016 ; Service Code 2K8197 , Lot Number 160730253M , Exp. Date 6/12/2016 ; Lot # 160770186M; Exp. 06/16 Lot # 160810189M; Exp. 06/16 Lot # 160840050M; Exp. 06/16 Lot # 160890231M; Exp. 06/16 Lot # 160910228M; Exp. 06/16 Lot # 160560020M; Exp. 05/16 Lot # 160610020C; Exp. 05/16 Lot # 160630014C; Exp. 06/16 Lot # 160660007C; Exp. 06/16 Lot # 160670052C; Exp. 06/16 Lot # 160680067C; Exp. 06/16 Lot # 160740037C; Exp. 06/16 Lot # 160740038C; Exp. 06/16 Lot # 160810067C; Exp. 06/16 Lot # 160840174M; Exp. 06/16 Lot # 160880157M; Exp. 06/16 Lot # 169000103M; Exp. 06/16 Lot # 160600222M; Exp. 05/16 Lot # 160740168M; Exp. 05/16 Lot # 160810051C ;Exp. 05/16 Lot # 160830031C; Exp. 06/16 Lot # 160880019C; Exp. 06/16 Lot # 160880175M; Exp. 06/16 Lot # 160950002C; Exp. 06/16 Lot # 160960172M; Exp. 07/16 Lot # 160950133M; Exp. 07/16

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-1362-2016
Classification
Class II
Status
Terminated
Recall initiated
May 5, 2016
FDA report date
Jul 27, 2016
Quantity
2,194 bags and cassettes
Recall type
Voluntary: Firm initiated
Recalling firm
Pharmedium Services, LLC

Original FDA data

Every field from FDA enforcement report D-1362-2016, 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
Service Code 2H8197 , Lot Number 160730048M , Exp. Date 6/12/2016 ; Service Code 2H8197 , Lot Number 160840111M , Exp. Date 6/22/2016 ; Service Code 2H8197 , Lot Number 160870066M , Exp. Date 6/25/2016 ; Service Code 2H8197 , Lot Number 160880208M , Exp. Date 6/27/2016 ; Service Code 2H8197 , Lot Number 160910038M , Exp. Date 6/29/2016 ; Service Code 2K8189 , Lot Number 160730049M , Exp. Date 6/11/2016 ; Service Code 2K8189 , Lot Number 160810152M , Exp. Date 6/20/2016 ; Service Code 2K8189 , Lot Number 160820330M , Exp. Date 6/21/2016 ; Service Code 2K8189 , Lot Number 160940135M , Exp. Date 7/3/2016 ; Service Code 2K8189 , Lot Number 160960178M , Exp. Date 7/5/2016 ; Service Code 2K8189 , Lot Number 160970201M , Exp. Date 7/6/2016 ; Service Code 2K8197 , Lot Number 160660178M , Exp. Date 6/5/2016 ; Service Code 2K8197 , Lot Number 160670161M , Exp. Date 6/6/2016 ; Service Code 2K8197 , Lot Number 160730253M , Exp. Date 6/12/2016 ; Lot # 160770186M; Exp. 06/16 Lot # 160810189M; Exp. 06/16 Lot # 160840050M; Exp. 06/16 Lot # 160890231M; Exp. 06/16 Lot # 160910228M; Exp. 06/16 Lot # 160560020M; Exp. 05/16 Lot # 160610020C; Exp. 05/16 Lot # 160630014C; Exp. 06/16 Lot # 160660007C; Exp. 06/16 Lot # 160670052C; Exp. 06/16 Lot # 160680067C; Exp. 06/16 Lot # 160740037C; Exp. 06/16 Lot # 160740038C; Exp. 06/16 Lot # 160810067C; Exp. 06/16 Lot # 160840174M; Exp. 06/16 Lot # 160880157M; Exp. 06/16 Lot # 169000103M; Exp. 06/16 Lot # 160600222M; Exp. 05/16 Lot # 160740168M; Exp. 05/16 Lot # 160810051C ;Exp. 05/16 Lot # 160830031C; Exp. 06/16 Lot # 160880019C; Exp. 06/16 Lot # 160880175M; Exp. 06/16 Lot # 160950002C; Exp. 06/16 Lot # 160960172M; Exp. 07/16 Lot # 160950133M; Exp. 07/16
Postal code
60045-2506
Report date
Jul 27, 2016
Product type
Drugs
Recall number
D-1362-2016
Classification
Class II
Recalling firm
Pharmedium Services, LLC
Product quantity
2,194 bags and cassettes
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
0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL White Smiths Medical Cassette (NDC 615530-933-11) f) 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ;
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-1362-2016, 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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