CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
0.1% Bupivacaine HCl (Preservative Free) recalled by Pharmedium Services
Pharmedium Services is recalling 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service, 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-1364-2016
- 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
0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8272(NDC 61553-272-52), 100 ml in 100 ml Yellow Smiths Medical Cassette Service Code 2K8941 (NDC 61553-941-48), 250 ml in 250 ml Baxter Intravia Bag (W/O Additive Cap) Service Code 3V8716, (NDC 61553-716-17), 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 2K8195 , Lot Number 160390084M , Exp. Date 5/9/2016 ; Service Code 2K8195 , Lot Number 160530298M , Exp. Date 5/23/2016 ; Service Code 2K8195 , Lot Number 160540203M , Exp. Date 5/24/2016 ; Service Code 2K8195 , Lot Number 160550182M , Exp. Date 5/25/2016 ; Service Code 2K8195 , Lot Number 160590153M , Exp. Date 5/29/2016 ; Service Code 2K8195 , Lot Number 160660150M , Exp. Date 6/5/2016 ; Service Code 2K8195 , Lot Number 160740115M , Exp. Date 6/12/2016 ; Service Code 2K8195 , Lot Number 160810295M , Exp. Date 6/20/2016 ; Service Code 2K8195 , Lot Number 160820217M , Exp. Date 6/21/2016 ; Service Code 2K8195 , Lot Number 160830164M , Exp. Date 6/21/2016 ; Service Code 2K8195 , Lot Number 160950236M , Exp. Date 7/4/2016 ; Service Code 2K8195 , Lot Number 160970203M , Exp. Date 7/6/2016 ; Service Code 2H8266 , Lot Number 160410177M , Exp. Date 5/11/2016 ; Service Code 2H8266 , Lot Number 160600056M , Exp. Date 5/29/2016 ; Service Code 2H8266 , Lot Number 160740185M , Exp. Date 6/13/2016 ; Service Code 2H8266 , Lot Number 160830175M , Exp. Date 6/22/2016 ; Service Code 2H8266 , Lot Number 160950218M , Exp. Date 7/4/2016 ; Service Code 2H8272 , Lot Number 160450150M , Exp. Date 5/15/2016 ; Service Code 2H8272 , Lot Number 160600070M , Exp. Date 5/29/2016 ; Service Code 2H8272 , Lot Number 160900043M , Exp. Date 6/28/2016 ; Service Code 2K8115 , Lot Number 160530135M , Exp. Date 5/23/2016 ; Service Code 2K8115 , Lot Number 160740158M , Exp. Date 6/13/2016 ; Service Code 2K8115 , Lot Number 160940047M , Exp. Date 7/2/2016 ; Service Code 2K8115 , Lot Number 160950158M , Exp. Date 7/4/2016 ; Service Code 2K8216 , Lot Number 160390353M , Exp. Date 5/9/2016 ; Service Code 2K8216 , Lot Number 160470237M , Exp. Date 5/17/2016 ; Service Code 2K8216 , Lot Number 160480276M , Exp. Date 5/18/2016 ; Service Code 2K8216 , Lot Number 160540026M , Exp. Date 5/24/2016 ; Service Code 2K8216 , Lot Number 160610271M , Exp. Date 5/31/2016 ; Service Code 2K8216 , Lot Number 160730105M , Exp. Date 6/12/2016 ; Service Code 2K8216 , Lot Number 160820198M , Exp. Date 6/21/2016 ; Service Code 2K8216 , Lot Number 160890280M , Exp. Date 6/28/2016 ; Service Code 2K8216 , Lot Number 160950038M , Exp. Date 7/4/2016 ; Service Code 2K8216 , Lot Number 161080329M , Exp. Date 7/17/2016 ; Service Code 2K8265 , Lot Number 160390177M , Exp. Date 5/9/2016 ; Service Code 2K8265 , Lot Number 160460174M , Exp. Date 5/16/2016 ; Service Code 2K8265 , Lot Number 160670198M , Exp. Date 6/6/2016 ; Service Code 2K8265 , Lot Number 160700004M , Exp. Date 6/8/2016 ; Service Code 2K8941 , Lot Number 160660352M , Exp. Date 5/15/2016 ; Service Code 2K8941 , Lot Number 160670183M , Exp. Date 5/16/2016 ; Service Code 2K8941 , Lot Number 160680195M , Exp. Date 5/17/2016 ; Service Code 2K8941 , Lot Number 160700129M , Exp. Date 5/18/2016 ; Service Code 2K8941 , Lot Number 160810184M , Exp. Date 5/30/2016 ; Service Code 2K8941 , Lot Number 160880172M , Exp. Date 6/5/2016 ; Service Code 2K8941 , Lot Number 160950159M , Exp. Date 6/13/2016 ; Service Code 2K8981 , Lot Number 160810255M , Exp. Date 5/30/2016 ; Service Code 2K8981 , Lot Number 160820101M , Exp. Date 5/30/2016 ; Service Code 2K8981 , Lot Number 160870158M , Exp. Date 6/5/2016 ; Service Code 2K8981 , Lot Number 160940056M , Exp. Date 6/12/2016 ; Service Code 2K9195 , Lot Number 160480120M , Exp. Date 5/18/2016 ; Service Code 2K9195 , Lot Number 160560132M , Exp. Date 5/26/2016 ; Service Code 2K9195 , Lot Number 160630008M , Exp. Date 6/1/2016 ; Service Code 2K9195 , Lot Number 160690115M , Exp. Date 6/8/2016 ; Service Code 2K9195 , Lot Number 160800136M , Exp. Date 6/19/2016 ; Service Code 2K9195 , Lot Number 160960023M , Exp. Date 7/5/2016 ; Service Code 2N1216 , Lot Number 160410171M , Exp. Date 5/11/2016 ; Service Code 2N1216 , Lot Number 160460136M , Exp. Date 5/16/2016 ; Service Code 2N1216 , Lot Number 160550200M , Exp. Date 5/25/2016 ; Service Code 2N1216 , Lot Number 160560092M , Exp. Date 5/25/2016 ; Service Code 2N1216 , Lot Number 160590070M , Exp. Date 5/29/2016 ; Service Code 2N1216 , Lot Number 160820128M , Exp. Date 6/21/2016 ; Service Code 2N1216 , Lot Number 160870064M , Exp. Date 6/25/2016 ; Service Code 2N1216 , Lot Number 160910029M , Exp. Date 6/29/2016 ; Service Code 2N1216 , Lot Number 160940046M , Exp. Date 7/2/2016 ; Service Code 2T8929 , Lot Number 160380099M , Exp. Date 5/7/2016 ; Service Code 2T8929 , Lot Number 160450107M , Exp. Date 5/14/2016 ; Service Code 2T8929 , Lot Number 160520098M , Exp. Date 5/21/2016 ; Service Code 2T8929 , Lot Number 160670039C , Exp. Date 6/6/2016 ; Service Code 2T8929 , Lot Number 160730024C , Exp. Date 6/12/2016 ; Service Code 2T8929 , Lot Number 160870018C , Exp. Date 6/25/2016 ; Service Code 2T8981 , Lot Number 160380016C , Exp. Date 5/8/2016 ; Service Code 2T8981 , Lot Number 160450021C , Exp. Date 5/15/2016 ; Service Code 2T8981 , Lot Number 160590008C , Exp. Date 5/29/2016 ; Service Code 2T8981 , Lot Number 160800031C , Exp. Date 6/19/2016 ; Service Code 2T8981 , Lot Number 160870012C , Exp. Date 6/26/2016 ; Service Code 3V8716 , Lot Number 160480036C , Exp. Date 5/18/2016 ; Service Code 3V8716 , Lot Number 160680034C , Exp. Date 6/7/2016 ; Service Code 3V8716 , Lot Number 160810069C , Exp. Date 6/20/2016 ; Service Code 3V8716 , Lot Number 160820048C , Exp. Date 6/21/2016 ; Service Code 3V8716 , Lot Number 160950060C , Exp. Date 7/4/2016 ;
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.
More recalls from Pharmedium Services
All 291| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| 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 |
| Drug | CLASS II | rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
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 | 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride recalled | Pharmedium Services | Particulate Matter | Nationwide |