CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride recalled
Pharmedium Services is recalling 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, distributed nationwide in the US. The recall was initiated on 5 May 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1368-2016
- FDA event ID
- 74057
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 May 2016
- FDA classified
- 16 Jul 2016
- Reported
- 27 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 5 May 2016 | Recall initiated by company | |
| 16 Jul 2016 | Classified by FDA | +72 days |
| 27 Jul 2016 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Product as listed by the FDA
0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2K8120 , NDC 61553-120-09 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2K8243 , NDC 61553-243-37 , 200 ml in 250 ml Baxter Intravia Bag ; , Service Code 2K9120 , NDC 61553-120-03 , 500 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N1120 , NDC 61553-120-84 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N9619 , NDC 61553-619-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Which lots are affected?
Service Code 2H8120 , Lot Number 160380137M , Exp. Date 5/8/2016 ; Service Code 2H8120 , Lot Number 160420181M , Exp. Date 5/12/2016 ; Service Code 2H8120 , Lot Number 160450166M , Exp. Date 5/15/2016 ; Service Code 2H8120 , Lot Number 160460209M , Exp. Date 5/16/2016 ; Service Code 2H8120 , Lot Number 160600277M , Exp. Date 5/30/2016 ; Service Code 2H8120 , Lot Number 160610057M , Exp. Date 5/30/2016 ; Service Code 2H8120 , Lot Number 160610224M , Exp. Date 5/31/2016 ; Service Code 2H8120 , Lot Number 160680153M , Exp. Date 6/7/2016 ; Service Code 2H8120 , Lot Number 160810219M , Exp. Date 6/20/2016 ; Service Code 2H8120 , Lot Number 160910124M , Exp. Date 6/29/2016 ; Service Code 2H8120 , Lot Number 160960220M , Exp. Date 7/5/2016 ; Service Code 2H8243 , Lot Number 160530200M , Exp. Date 5/9/2016 ; Service Code 2H8243 , Lot Number 160600047M , Exp. Date 5/16/2016 ; Service Code 2H8243 , Lot Number 160670033M , Exp. Date 5/22/2016 ; Service Code 2H8243 , Lot Number 160810051M , Exp. Date 6/5/2016 ; Service Code 2H8243 , Lot Number 160880267M , Exp. Date 6/13/2016 ; Service Code 2H8243 , Lot Number 160910035M , Exp. Date 6/15/2016 ; Service Code 2H8243 , Lot Number 160950059M , Exp. Date 6/19/2016 ; Service Code 2K8120 , Lot Number 160480190M , Exp. Date 5/18/2016 ; Service Code 2K8120 , Lot Number 160550194M , Exp. Date 5/25/2016 ; Service Code 2K8120 , Lot Number 160940060M , Exp. Date 7/2/2016 ; Service Code 2K8243 , Lot Number 160410183M , Exp. Date 5/11/2016 ; Service Code 2K8243 , Lot Number 160420152M , Exp. Date 5/12/2016 ; Service Code 2K8243 , Lot Number 160460131M , Exp. Date 5/16/2016 ; Service Code 2K8243 , Lot Number 160490239M , Exp. Date 5/19/2016 ; Service Code 2K8243 , Lot Number 160520184M , Exp. Date 5/22/2016 ; Service Code 2K8243 , Lot Number 160550125M , Exp. Date 5/25/2016 ; Service Code 2K8243 , Lot Number 160590160M , Exp. Date 5/29/2016 ; Service Code 2K8243 , Lot Number 160600171M , Exp. Date 5/30/2016 ; Service Code 2K8243 , Lot Number 160610227M , Exp. Date 5/31/2016 ; Service Code 2K8243 , Lot Number 160620142M , Exp. Date 6/1/2016 ; Service Code 2K8243 , Lot Number 160630199M , Exp. Date 6/2/2016 ; Service Code 2K8243 , Lot Number 160660168M , Exp. Date 6/5/2016 ; Service Code 2K8243 , Lot Number 160670236M , Exp. Date 6/6/2016 ; Service Code 2K8243 , Lot Number 160700192M , Exp. Date 6/9/2016 ; Service Code 2K8243 , Lot Number 160740235M , Exp. Date 6/13/2016 ; Service Code 2K8243 , Lot Number 160760190M , Exp. Date 6/15/2016 ; Service Code 2K8243 , Lot Number 160810280M , Exp. Date 6/20/2016 ; Service Code 2K8243 , Lot Number 160820234M , Exp. Date 6/21/2016 ; Service Code 2K8243 , Lot Number 160830120M , Exp. Date 6/21/2016 ; Service Code 2K8243 , Lot Number 160870168M , Exp. Date 6/26/2016 ; Service Code 2K8243 , Lot Number 160900173M , Exp. Date 6/29/2016 ; Service Code 2K8243 , Lot Number 160910176M , Exp. Date 6/30/2016 ; Service Code 2K8243 , Lot Number 160940041M , Exp. Date 7/2/2016 ; Service Code 2K8243 , Lot Number 161080168M , Exp. Date 7/17/2016 ; Service Code 2K9120 , Lot Number 160380034C , Exp. Date 5/8/2016 ; Service Code 2K9120 , Lot Number 160380105M , Exp. Date 5/8/2016 ; Service Code 2K9120 , Lot Number 160420030C , Exp. Date 5/12/2016 ; Service Code 2K9120 , Lot Number 160470039C , Exp. Date 5/17/2016 ; Service Code 2K9120 , Lot Number 160540034C , Exp. Date 5/24/2016 ; Service Code 2K9120 , Lot Number 160550029C , Exp. Date 5/25/2016 ; Service Code 2K9120 , Lot Number 160590078M , Exp. Date 5/29/2016 ; Service Code 2K9120 , Lot Number 160600067M , Exp. Date 5/29/2016 ; Service Code 2K9120 , Lot Number 160670187M , Exp. Date 6/6/2016 ; Service Code 2K9120 , Lot Number 160730076M , Exp. Date 6/11/2016 ; Service Code 2K9120 , Lot Number 160750233M , Exp. Date 6/14/2016 ; Service Code 2K9120 , Lot Number 160770001M , Exp. Date 6/15/2016 ; Service Code 2K9120 , Lot Number 160770049M , Exp. Date 6/15/2016 ; Service Code 2K9120 , Lot Number 160810056M , Exp. Date 6/19/2016 ; Service Code 2K9120 , Lot Number 160870069M , Exp. Date 6/26/2016 ; Service Code 2K9120 , Lot Number 160910184M , Exp. Date 6/30/2016 ; Service Code 2K9120 , Lot Number 160940154M , Exp. Date 7/3/2016 ; Service Code 2K9120 , Lot Number 160960190M , Exp. Date 7/5/2016 ; Service Code 2K9120 , Lot Number 161080156M , Exp. Date 7/17/2016 ; Service Code 2N1120 , Lot Number 160960241M , Exp. Date 7/5/2016 ; Service Code 2N9619 , Lot Number 160950229M , Exp. Date 7/4/2016 ; Service Code 2R3317-5 , Lot Number 160420122M , Exp. Date 5/12/2016 ; Service Code 2R3317-5 , Lot Number 160550206M , Exp. Date 5/24/2016 ; Service Code 2R3317-5 , Lot Number 160590164M , Exp. Date 5/29/2016 ; Service Code 2R3317-5 , Lot Number 160660159M , Exp. Date 6/5/2016 ; Service Code 2R3317-5 , Lot Number 160690151M , Exp. Date 6/7/2016 ; Service Code 2R3317-5 , Lot Number 160740252M , Exp. Date 6/13/2016 ; Service Code 2R3317-5 , Lot Number 160750181M , Exp. Date 6/14/2016 ; Service Code 2R3317-5 , Lot Number 160810298M , Exp. Date 6/20/2016 ; Service Code 2R3317-5 , Lot Number 160830222M , Exp. Date 6/22/2016 ; Service Code 2R3317-5 , Lot Number 160940150M , Exp. Date 7/3/2016 ; Service Code 2R3317-5 , Lot Number 161080209M , Exp. Date 7/17/2016 ; Service Code 3317NO , Lot Number 160380157M , Exp. Date 5/8/2016 ; Service Code 3317NO , Lot Number 160420173M , Exp. Date 5/11/2016 ; Service Code 3317NO , Lot Number 160540140M , Exp. Date 5/24/2016 ; Service Code 3317NO , Lot Number 160600185M , Exp. Date 5/30/2016 ; Service Code 3317NO , Lot Number 160630204M , Exp. Date 6/2/2016 ; Service Code 3317NO , Lot Number 160660172M , Exp. Date 6/5/2016 ; Service Code 3317NO , Lot Number 160700219M , Exp. Date 6/9/2016 ; Service Code 3317NO , Lot Number 160770174M , Exp. Date 6/16/2016 ; Service Code 3317NO , Lot Number 160840205M , Exp. Date 6/23/2016 ; Service Code 3317NO , Lot Number 160910210M , Exp. Date 6/30/2016 ; Service Code 3317NO , Lot Number 161080215M , Exp. Date 7/17/2016 ;
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
74 other products · FDA event 74057This product is part of a recall event; the main page for the event is 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl recalled.
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| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
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| Drug | CLASS II | fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
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Other Bupivacaine (preservative Free recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 0.125% Bupivacaine HCl (Preservative Free) recalled | Pharmedium Services | Particulate Matter | Nationwide |
| Drug | CLASS II | 0.03% Bupivacaine HCl (Preservative Free) recalled | Pharmedium Services | Particulate Matter | Nationwide |
| Drug | CLASS II | 0.5% Bupivacaine HCl (Preservative Free) recalled by Pharmedium Services | Pharmedium Services | Particulate Matter | Nationwide |
| Drug | CLASS II | 0.0625% Bupivacaine HCl (Preservative Free) recalled | Pharmedium Services | Particulate Matter | Nationwide |
| Drug | CLASS II | 0.1% Bupivacaine HCl (Preservative Free) recalled by Pharmedium Services | Pharmedium Services | Particulate Matter | Nationwide |