CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
0.5% Bupivacaine HCl (Preservative Free) recalled by Pharmedium Services
Pharmedium Services is recalling 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride in Baxter Intravia, 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-1372-2016
- 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
0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)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 2N1488 , Lot Number 160520176M , Exp. Date 5/22/2016 ; Service Code 2N1488 , Lot Number 160600059M , Exp. Date 5/30/2016 ; Service Code 2N1488 , Lot Number 160970115M , Exp. Date 7/5/2016 ; Service Code 2N1489 , Lot Number 160490027C , Exp. Date 5/19/2016 ; Service Code 2N1489 , Lot Number 160560032C , Exp. Date 5/26/2016 ; Service Code 2N1489 , Lot Number 160620024C , Exp. Date 6/1/2016 ; Service Code 2N1489 , Lot Number 160630029C , Exp. Date 6/2/2016 ; Service Code 2N1489 , Lot Number 160670059C , Exp. Date 6/6/2016 ; Service Code 2N1489 , Lot Number 160700047C , Exp. Date 6/9/2016 ; Service Code 2N1489 , Lot Number 160730025C , Exp. Date 6/12/2016 ; Service Code 2N1489 , Lot Number 160810057C , Exp. Date 6/20/2016 ; Service Code 2R3332-5 , Lot Number 160420156M , Exp. Date 5/11/2016 ; Service Code 2R3332-5 , Lot Number 160470152M , Exp. Date 5/16/2016 ; Service Code 2R3332-5 , Lot Number 160620035M , Exp. Date 5/31/2016 ; Service Code 2R3332-5 , Lot Number 160770159M , Exp. Date 6/16/2016 ; Service Code 2R3332-5 , Lot Number 160830044M , Exp. Date 6/21/2016 ; Service Code 2R3332-5 , Lot Number 160970032M , Exp. Date 7/5/2016 ; Service Code 3332NO , Lot Number 160380115M , Exp. Date 5/7/2016 ; Service Code 3332NO , Lot Number 160420112M , Exp. Date 5/11/2016 ; Service Code 3332NO , Lot Number 160540138M , Exp. Date 5/24/2016 ; Service Code 3332NO , Lot Number 160660215M , Exp. Date 6/5/2016 ; Service Code 3332NO , Lot Number 160690125M , Exp. Date 6/7/2016 ; Service Code 3332NO , Lot Number 160750228M , Exp. Date 6/14/2016 ; Service Code 3332NO , Lot Number 160900145M , Exp. Date 6/28/2016 ; Service Code 3332NO , Lot Number 160950153M , 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 | 0.0625% 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 |
| Drug | CLASS II | 0.1% Bupivacaine HCl (Preservative Free) recalled by Pharmedium Services | Pharmedium Services | Particulate Matter | Nationwide |