0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira Life...
FDA Drug Recall #D-1365-2016 — Class II — May 5, 2016
Recall Summary
| Recall Number | D-1365-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 5, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pharmedium Services, LLC |
| Location | Lake Forest, IL |
| Product Type | Drugs |
| Quantity | 8,581 bags |
Product Description
0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Reason for Recall
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Distribution Pattern
Nationwide
Lot / Code Information
Service Code 2C8192 , Lot Number 160830033M , Exp. Date 5/7/2016 ; Service Code 2H8192 , Lot Number 160380144M , Exp. Date 5/8/2016 ; Service Code 2H8192 , Lot Number 160480178M , Exp. Date 5/18/2016 ; Service Code 2H8192 , Lot Number 160610225M , Exp. Date 5/31/2016 ; Service Code 2H8192 , Lot Number 160690186M , Exp. Date 6/8/2016 ; Service Code 2H8192 , Lot Number 160730071M , Exp. Date 6/12/2016 ; Service Code 2H8192 , Lot Number 160760041M , Exp. Date 6/14/2016 ; Service Code 2H8192 , Lot Number 160820212M , Exp. Date 6/21/2016 ; Service Code 2H8192 , Lot Number 160880171M , Exp. Date 6/27/2016 ; Service Code 2H8192 , Lot Number 160940141M , Exp. Date 7/3/2016 ; Service Code 2H8192 , Lot Number 160950053M , Exp. Date 7/3/2016 ; Service Code 2H8194 , Lot Number 160410184M , Exp. Date 5/11/2016 ; Service Code 2H8194 , Lot Number 160540217M , Exp. Date 5/24/2016 ; Service Code 2H8194 , Lot Number 160550223M , Exp. Date 5/25/2016 ; Service Code 2H8194 , Lot Number 160590170M , Exp. Date 5/29/2016 ; Service Code 2H8194 , Lot Number 160630202M , Exp. Date 6/2/2016 ; Service Code 2H8194 , Lot Number 160660049M , Exp. Date 6/4/2016 ; Service Code 2H8194 , Lot Number 160740150M , Exp. Date 6/13/2016 ; Service Code 2H8194 , Lot Number 160750224M , Exp. Date 6/14/2016 ; Service Code 2H8194 , Lot Number 160760187M , Exp. Date 6/15/2016 ; Service Code 2H8194 , Lot Number 160810145M , Exp. Date 6/19/2016 ; Service Code 2H8194 , Lot Number 160840152M , Exp. Date 6/23/2016 ; Service Code 2H8194 , Lot Number 160870050M , Exp. Date 6/25/2016 ; Service Code 2H8194 , Lot Number 160880248M , Exp. Date 6/27/2016 ; Service Code 2H8194 , Lot Number 160900001M , Exp. Date 6/28/2016 ; Service Code 2H8194 , Lot Number 160910151M , Exp. Date 6/30/2016 ; Service Code 2H8194 , Lot Number 160950209M , Exp. Date 7/4/2016 ; Service Code 2H8194 , Lot Number 160960222M , Exp. Date 7/5/2016 ; Service Code 2H8194 , Lot Number 161080218M , Exp. Date 7/17/2016 ; Service Code 2K8117 , Lot Number 160390199M , Exp. Date 5/9/2016 ; Service Code 2K8117 , Lot Number 160450108M , Exp. Date 5/15/2016 ; Service Code 2K8117 , Lot Number 160530282M , Exp. Date 5/23/2016 ; Service Code 2K8117 , Lot Number 160600287M , Exp. Date 5/30/2016 ; Service Code 2K8117 , Lot Number 160670229M , Exp. Date 6/6/2016 ; Service Code 2K8117 , Lot Number 160730046M , Exp. Date 6/11/2016 ; Service Code 2K8117 , Lot Number 160880218M , Exp. Date 6/27/2016 ; Service Code 2K8117 , Lot Number 160950211M , Exp. Date 7/4/2016 ; Service Code 2K8169 , Lot Number 160380140M , Exp. Date 5/8/2016 ; Service Code 2K8169 , Lot Number 160540205M , Exp. Date 5/24/2016 ; Service Code 2K8169 , Lot Number 160550192M , Exp. Date 5/25/2016 ; Service Code 2K8169 , Lot Number 160600071M , Exp. Date 5/30/2016 ; Service Code 2K8169 , Lot Number 160750182M , Exp. Date 6/14/2016 ; Service Code 2K8169 , Lot Number 160820048M , Exp. Date 6/20/2016 ; Service Code 2K8169 , Lot Number 160950042M , Exp. Date 7/3/2016 ; Service Code 2K8191 , Lot Number 160450060M , Exp. Date 5/14/2016 ; Service Code 2K8191 , Lot Number 160520050M , Exp. Date 5/21/2016 ; Service Code 2K8191 , Lot Number 160590082M , Exp. Date 5/29/2016 ; Service Code 2K8191 , Lot Number 160660148M , Exp. Date 6/5/2016 ; Service Code 2K8191 , Lot Number 160740190M , Exp. Date 6/13/2016 ; Service Code 2K8191 , Lot Number 160770248M , Exp. Date 6/16/2016 ; Service Code 2K8191 , Lot Number 160840226M , Exp. Date 6/23/2016 ; Service Code 2K8191 , Lot Number 160890194M , Exp. Date 6/28/2016 ; Service Code 2K8191 , Lot Number 160940236M , Exp. Date 7/3/2016 ; Service Code 2K8192 , Lot Number 160380092M , Exp. Date 5/8/2016 ; Service Code 2K8192 , Lot Number 160410238M , Exp. Date 5/11/2016 ; Service Code 2K8192 , Lot Number 160450076M , Exp. Date 5/15/2016 ; Service Code 2K8192 , Lot Number 160490050M , Exp. Date 5/19/2016 ; Service Code 2K8192 , Lot Number 160550039M , Exp. Date 5/25/2016 ; Service Code 2K8192 , Lot Number 160560317M , Exp. Date 5/26/2016 ; Service Code 2K8192 , Lot Number 160610063M , Exp. Date 5/31/2016 ; Service Code 2K8192 , Lot Number 160620324M , Exp. Date 6/1/2016 ; Service Code 2K8192 , Lot Number 160690057M , Exp. Date 6/8/2016 ; Service Code 2K8192 , Lot Number 160750125M , Exp. Date 6/14/2016 ; Service Code 2K8192 , Lot Number 160750126M , Exp. Date 6/14/2016 ; Service Code 2K8192 , Lot Number 160810039M , Exp. Date 6/20/2016 ; Service Code 2K8192 , Lot Number 160810239M , Exp. Date 6/20/2016 ; Service Code 2K8192 , Lot Number 160840048M , Exp. Date 6/23/2016 ; Service Code 2K8192 , Lot Number 160870337M , Exp. Date 6/26/2016 ; Service Code 2K8192 , Lot Number 160910053M , Exp. Date 6/30/2016 ; Service Code 2K8192 , Lot Number 160950331M , Exp. Date 7/4/2016 ; Service Code 2K8192 , Lot Number 160970298M , Exp. Date 7/6/2016 ; Service Code 2K8294 , Lot Number 160390214M , Exp. Date 5/9/2016 ; Service Code 2K8294 , Lot Number 160420153M , Exp. Date 5/11/2016 ; Service Code 2K8294 , Lot Number 160470179M , Exp. Date 5/17/2016 ; Service Code 2K8294 , Lot Number 160480224M , Exp. Date 5/18/2016 ; Service Code 2K8294 , Lot Number 160540201M , Exp. Date 5/24/2016 ; Service Code 2K8294 , Lot Number 160550225M , Exp. Date 5/25/2016 ; Service Code 2K8294 , Lot Number 160610240M , Exp. Date 5/31/2016 ; Service Code 2K8294 , Lot Number 160620116M , Exp. Date 6/1/2016 ; Service Code 2K8294 , Lot Number 160670192M , Exp. Date 6/6/2016 ; Service Code 2K8294 , Lot Number 160730159M , Exp. Date 6/12/2016 ; Service Code 2K8294 , Lot Number 160740236M , Exp. Date 6/13/2016 ; Service Code 2K8294 , Lot Number 160750217M , Exp. Date 6/14/2016 ; Service Code 2K8294 , Lot Number 160760191M , Exp. Date 6/15/2016 ; Service Code 2K8294 , Lot Number 160810209M , Exp. Date 6/20/2016 ; Service Code 2K8294 , Lot Number 160820204M , Exp. Date 6/21/2016 ; Service Code 2K8294 , Lot Number 160830177M , Exp. Date 6/22/2016 ; Service Code 2K8294 , Lot Number 160840105M , Exp. Date 6/22/2016 ; Service Code 2K8294 , Lot Number 160900165M , Exp. Date 6/29/2016 ; Service Code 2K8294 , Lot Number 160910116M , Exp. Date 6/29/2016 ; Service Code 2K8294 , Lot Number 160960226M , Exp. Date 7/5/2016 ; Service Code 2K8294 , Lot Number 161080230M , Exp. Date 7/17/2016 ; Service Code 2K8829 , Lot Number 160600054C , Exp. Date 5/9/2016 ; Service Code 2K8829 , Lot Number 160620028C , Exp. Date 5/11/2016 ; Service Code 2K8829 , Lot Number 160670050C , Exp. Date 5/16/2016 ; Service Code 2K8829 , Lot Number 160680048C , Exp. Date 5/17/2016 ; Service Code 2K8829 , Lot Number 160740061C , Exp. Date 5/23/2016 ; Service Code 2K8829 , Lot Number 160810072C , Exp. Date 5/30/2016 ; Service Code 2K8829 , Lot Number 160870029C , Exp. Date 6/5/2016 ; Service Code 2K8829 , Lot Number 160950049C , Exp. Date 6/13/2016 ; Service Code 2K8881 , Lot Number 160670060C , Exp. Date 5/16/2016 ; Service Code 2K8881 , Lot Number 160740062C , Exp. Date 5/23/2016 ; Service Code 2K8881 , Lot Number 160810068C , Exp. Date 5/30/2016 ; Service Code 2K8881 , Lot Number 160880036C , Exp. Date 6/6/2016 ; Service Code 2K8881 , Lot Number 160910019C , Exp. Date 6/9/2016 ; Service Code 2K8881 , Lot Number 160950074C , Exp. Date 6/13/2016 ; Service Code 2K8882 , Lot Number 160620027C , Exp. Date 5/11/2016 ; Service Code 2K8882 , Lot Number 160760043C , Exp. Date 5/25/2016 ; Service Code 2K8882 , Lot Number 160810075C , Exp. Date 5/30/2016 ; Service Code 2K8882 , Lot Number 160830062C , Exp. Date 6/1/2016 ; Service Code 2K8882 , Lot Number 160880071C , Exp. Date 6/6/2016 ; Service Code 2K8882 , Lot Number 160900112C , Exp. Date 6/8/2016 ; Service Code 2K8930 , Lot Number 160970150M , Exp. Date 5/7/2016 ; Service Code 2K8930 , Lot Number 160970151M , Exp. Date 5/7/2016 ; Service Code 2K8930 , Lot Number 161080317M , Exp. Date 5/18/2016 ; Service Code 2N1117 , Lot Number 160420020C , Exp. Date 5/12/2016 ; Service Code 2N1117 , Lot Number 160470032C , Exp. Date 5/17/2016 ; Service Code 2N1117 , Lot Number 160550028C , Exp. Date 5/25/2016 ; Service Code 2N1117 , Lot Number 160680029C , Exp. Date 6/7/2016 ; Service Code 2N1117 , Lot Number 160770039C , Exp. Date 6/16/2016 ; Service Code 2N1117 , Lot Number 160830043C , Exp. Date 6/22/2016 ; Service Code 2N1117 , Lot Number 160880056C , Exp. Date 6/27/2016 ; Service Code 2N1117 , Lot Number 160960026C , Exp. Date 7/5/2016 ; Service Code 2N1192 , Lot Number 160400192M , Exp. Date 5/10/2016 ; Service Code 2N1192 , Lot Number 160480196M , Exp. Date 5/18/2016 ; Service Code 2N1192 , Lot Number 160550005M , Exp. Date 5/24/2016 ; Service Code 2N1192 , Lot Number 160550118M , Exp. Date 5/25/2016 ; Service Code 2N1192 , Lot Number 160560204M , Exp. Date 5/26/2016 ; Service Code 2N1192 , Lot Number 160570006M , Exp. Date 5/26/2016 ; Service Code 2N1192 , Lot Number 160590060M , Exp. Date 5/29/2016 ; Service Code 2N1192 , Lot Number 160690038M , Exp. Date 6/7/2016 ; Service Code 2N1192 , Lot Number 160800071M , Exp. Date 6/18/2016 ; Service Code 2N1192 , Lot Number 160830047M , Exp. Date 6/21/2016 ; Service Code 2N1192 , Lot Number 160900125M , Exp. Date 6/28/2016 ; Service Code 2N1192 , Lot Number 160910122M , Exp. Date 6/29/2016 ; Service Code 2N1918 , Lot Number 160960017C , Exp. Date 5/6/2016 ; Service Code 2N1918 , Lot Number 160970017C , Exp. Date 5/7/2016 ; Service Code 3V8719 , Lot Number 160420031C , Exp. Date 5/12/2016 ; Service Code 3V8719 , Lot Number 160480039C , Exp. Date 5/18/2016 ; Service Code 3V8719 , Lot Number 160540029C , Exp. Date 5/24/2016 ; Service Code 3V8719 , Lot Number 160610038C , Exp. Date 5/31/2016 ; Service Code 3V8719 , Lot Number 160700003C , Exp. Date 6/9/2016 ; Service Code 3V8719 , Lot Number 160760033C , Exp. Date 6/15/2016 ; Service Code 3V8719 , Lot Number 160830047C , Exp. Date 6/22/2016 ; Service Code 3V8719 , Lot Number 160900111C , Exp. Date 6/29/2016 ; Service Code 3V8719 , Lot Number 160970031C , Exp. Date 7/6/2016 ;
Other Recalls from Pharmedium Services, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1087-2020 | Class II | rocuronium Bromide, 10 mg per mL, 50 mg per 5 m... | Mar 16, 2020 |
| D-1088-2020 | Class II | ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL ... | Mar 16, 2020 |
| D-1085-2020 | Class II | fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 2... | Mar 16, 2020 |
| D-1082-2020 | Class II | nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9%... | Mar 16, 2020 |
| D-1083-2020 | Class II | rocuronium Bromide 10 mg per mL 50 mg per 5 mL,... | Mar 16, 2020 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.