5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride...
FDA Drug Recall #D-1423-2016 — Class II — May 5, 2016
Recall Summary
| Recall Number | D-1423-2016 |
| 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 | 3,474 bags |
Product Description
5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8447 , NDC 61553-447-25 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9135 , NDC 61553-135-10 , 350 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9915 , NDC 61553-915-97 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 4J8136 , NDC 61553-136-97 , 250 ml in 250 ml Baxter Intravia Bag ; 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 2H8136 , Lot Number 160390196M , Exp. Date 5/9/2016 ; Service Code 2H8136 , Lot Number 160400231M , Exp. Date 5/10/2016 ; Service Code 2H8136 , Lot Number 160410114M , Exp. Date 5/11/2016 ; Service Code 2H8136 , Lot Number 160460187M , Exp. Date 5/16/2016 ; Service Code 2H8136 , Lot Number 160490237M , Exp. Date 5/19/2016 ; Service Code 2H8136 , Lot Number 160520172M , Exp. Date 5/22/2016 ; Service Code 2H8136 , Lot Number 160530288M , Exp. Date 5/23/2016 ; Service Code 2H8136 , Lot Number 160600186M , Exp. Date 5/30/2016 ; Service Code 2H8136 , Lot Number 160630207M , Exp. Date 6/2/2016 ; Service Code 2H8136 , Lot Number 160670243M , Exp. Date 6/6/2016 ; Service Code 2H8136 , Lot Number 160730070M , Exp. Date 6/11/2016 ; Service Code 2H8136 , Lot Number 160740213M , Exp. Date 6/13/2016 ; Service Code 2H8136 , Lot Number 160810151M , Exp. Date 6/20/2016 ; Service Code 2H8136 , Lot Number 160830114M , Exp. Date 6/22/2016 ; Service Code 2H8136 , Lot Number 160880266M , Exp. Date 6/27/2016 ; Service Code 2H8136 , Lot Number 160950223M , Exp. Date 7/4/2016 ; Service Code 2H8136 , Lot Number 160960179M , Exp. Date 7/5/2016 ; Service Code 2H8136 , Lot Number 161080119M , Exp. Date 7/17/2016 ; Service Code 2K8135 , Lot Number 160390318M , Exp. Date 5/9/2016 ; Service Code 2K8135 , Lot Number 160450256M , Exp. Date 5/15/2016 ; Service Code 2K8135 , Lot Number 160520144M , Exp. Date 5/22/2016 ; Service Code 2K8135 , Lot Number 160660248M , Exp. Date 6/5/2016 ; Service Code 2K8135 , Lot Number 160730089M , Exp. Date 6/12/2016 ; Service Code 2K8135 , Lot Number 160840235M , Exp. Date 6/23/2016 ; Service Code 2K8135 , Lot Number 160950175M , Exp. Date 7/4/2016 ; Service Code 2K8136 , Lot Number 160470209M , Exp. Date 5/11/2016 ; Service Code 2K8136 , Lot Number 160490159M , Exp. Date 5/13/2016 ; Service Code 2K8136 , Lot Number 160560128M , Exp. Date 5/20/2016 ; Service Code 2K8136 , Lot Number 160600250M , Exp. Date 5/24/2016 ; Service Code 2K8136 , Lot Number 160660268M , Exp. Date 5/30/2016 ; Service Code 2K8136 , Lot Number 160730128M , Exp. Date 6/6/2016 ; Service Code 2K8136 , Lot Number 160770110M , Exp. Date 6/10/2016 ; Service Code 2K8136 , Lot Number 160810309M , Exp. Date 6/14/2016 ; Service Code 2K8136 , Lot Number 160840046M , Exp. Date 6/17/2016 ; Service Code 2K8136 , Lot Number 160890166M , Exp. Date 6/22/2016 ; Service Code 2K8136 , Lot Number 160970110M , Exp. Date 6/30/2016 ; Service Code 2K8136 , Lot Number 161080316M , Exp. Date 7/11/2016 ; Service Code 2K8447 , Lot Number 160480124M , Exp. Date 5/12/2016 ; Service Code 2K8447 , Lot Number 160560102M , Exp. Date 5/19/2016 ; Service Code 2K8447 , Lot Number 160620043M , Exp. Date 5/25/2016 ; Service Code 2K8447 , Lot Number 160820219M , Exp. Date 6/15/2016 ; Service Code 2K8945 , Lot Number 160460179M , Exp. Date 5/6/2016 ; Service Code 2K8945 , Lot Number 160680052M , Exp. Date 5/28/2016 ; Service Code 2K8945 , Lot Number 160890253M , Exp. Date 6/19/2016 ; Service Code 2K8984 , Lot Number 160490124M , Exp. Date 5/9/2016 ; Service Code 2K8984 , Lot Number 160530219M , Exp. Date 5/14/2016 ; Service Code 2K8984 , Lot Number 160550193M , Exp. Date 5/15/2016 ; Service Code 2K8984 , Lot Number 160620141M , Exp. Date 5/23/2016 ; Service Code 2K8984 , Lot Number 160690159M , Exp. Date 5/30/2016 ; Service Code 2K8984 , Lot Number 160750189M , Exp. Date 6/5/2016 ; Service Code 2K8984 , Lot Number 160820117M , Exp. Date 6/11/2016 ; Service Code 2K8984 , Lot Number 161080172M , Exp. Date 7/8/2016 ; Service Code 2K9135 , Lot Number 160520112M , Exp. Date 5/16/2016 ; Service Code 2K9135 , Lot Number 160600209M , Exp. Date 5/24/2016 ; Service Code 2K9135 , Lot Number 160620189M , Exp. Date 5/26/2016 ; Service Code 2K9135 , Lot Number 160660051M , Exp. Date 5/29/2016 ; Service Code 2K9135 , Lot Number 160830126M , Exp. Date 6/15/2016 ; Service Code 2K9135 , Lot Number 160890180M , Exp. Date 6/22/2016 ; Service Code 2K9135 , Lot Number 160910126M , Exp. Date 6/24/2016 ; Service Code 2K9915 , Lot Number 160620026C , Exp. Date 5/26/2016 ; Service Code 2K9915 , Lot Number 160740050C , Exp. Date 6/7/2016 ; Service Code 2K9915 , Lot Number 160810059C , Exp. Date 6/15/2016 ; Service Code 2T6135 , Lot Number 160400229M , Exp. Date 5/10/2016 ; Service Code 2T6135 , Lot Number 160450178M , Exp. Date 5/15/2016 ; Service Code 2T6135 , Lot Number 160490241M , Exp. Date 5/19/2016 ; Service Code 2T6135 , Lot Number 160620220M , Exp. Date 6/1/2016 ; Service Code 2T6135 , Lot Number 160680050M , Exp. Date 6/6/2016 ; Service Code 2T6135 , Lot Number 160810281M , Exp. Date 6/20/2016 ; Service Code 2T6135 , Lot Number 160940052M , Exp. Date 7/2/2016 ; Service Code 2T6135 , Lot Number 160950068M , Exp. Date 7/4/2016 ; Service Code 4J8136 , Lot Number 160460142M , Exp. Date 5/10/2016 ; Service Code 4J8136 , Lot Number 160680034M , Exp. Date 5/31/2016 ; Service Code 4J8136 , Lot Number 160740033M , Exp. Date 6/6/2016 ; Service Code 4J8136 , Lot Number 160880020M , Exp. Date 6/20/2016 ; Service Code 4J8136 , Lot Number 160950048M , Exp. Date 6/27/2016 ;
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.