5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 5...
FDA Drug Recall #D-1425-206 — Class II — May 5, 2016
Recall Summary
| Recall Number | D-1425-206 |
| 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 | 2,713 syringes |
Product Description
5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20
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 2H8138 , Lot Number 160410192M , Exp. Date 5/11/2016 ; Service Code 2H8138 , Lot Number 160600314M , Exp. Date 5/30/2016 ; Service Code 2H8138 , Lot Number 160690002M , Exp. Date 6/7/2016 ; Service Code 2H8138 , Lot Number 160690191M , Exp. Date 6/8/2016 ; Service Code 2H8138 , Lot Number 160740233M , Exp. Date 6/13/2016 ; Service Code 2H8138 , Lot Number 160760163M , Exp. Date 6/14/2016 ; Service Code 2H8138 , Lot Number 160830226M , Exp. Date 6/22/2016 ; Service Code 2H8138 , Lot Number 160890256M , Exp. Date 6/28/2016 ; Service Code 2H8138 , Lot Number 160940138M , Exp. Date 7/3/2016 ; Service Code 2H8138 , Lot Number 160960197M , Exp. Date 7/5/2016 ; Service Code 2H8138 , Lot Number 161080219M , Exp. Date 7/17/2016 ; Service Code 2K8138 , Lot Number 160450061M , Exp. Date 5/9/2016 ; Service Code 2K8138 , Lot Number 160470232M , Exp. Date 5/11/2016 ; Service Code 2K8138 , Lot Number 160480268M , Exp. Date 5/12/2016 ; Service Code 2K8138 , Lot Number 160590083M , Exp. Date 5/23/2016 ; Service Code 2K8138 , Lot Number 160630170M , Exp. Date 5/27/2016 ; Service Code 2K8138 , Lot Number 160690170M , Exp. Date 6/2/2016 ; Service Code 2K8138 , Lot Number 160700150M , Exp. Date 6/3/2016 ; Service Code 2K8138 , Lot Number 160770283M , Exp. Date 6/10/2016 ; Service Code 2K8138 , Lot Number 160840146M , Exp. Date 6/17/2016 ; Service Code 2K8138 , Lot Number 160910269M , Exp. Date 6/24/2016 ; Service Code 2K8138 , Lot Number 161080325M , Exp. Date 7/11/2016 ; Service Code 2K8807 , Lot Number 160490044C , Exp. Date 5/10/2016 ; Service Code 2K8807 , Lot Number 160630012C , Exp. Date 5/24/2016 ; Service Code 2K8807 , Lot Number 160700033C , Exp. Date 5/31/2016 ; Service Code 2K8807 , Lot Number 160970033C , Exp. Date 6/27/2016 ; Service Code 2K8872 , Lot Number 160600059C , Exp. Date 5/21/2016 ; Service Code 2K8872 , Lot Number 160630026C , Exp. Date 5/24/2016 ; Service Code 2K8872 , Lot Number 160660158M , Exp. Date 5/27/2016 ; Service Code 2K8872 , Lot Number 160740036M , Exp. Date 6/3/2016 ; Service Code 2K8872 , Lot Number 160880252M , Exp. Date 6/18/2016 ; Service Code 2K8872 , Lot Number 160940031C , Exp. Date 6/24/2016 ; Service Code 2K9138 , Lot Number 160420038C , Exp. Date 5/12/2016 ; Service Code 2K9138 , Lot Number 160460045C , Exp. Date 5/16/2016 ; Service Code 2K9138 , Lot Number 160520033C , Exp. Date 5/22/2016 ; Service Code 2K9138 , Lot Number 160530050C , Exp. Date 5/23/2016 ; Service Code 2K9138 , Lot Number 160590029C , Exp. Date 5/29/2016 ; Service Code 2K9138 , Lot Number 160600062C , Exp. Date 5/30/2016 ; Service Code 2K9138 , Lot Number 160630033C , Exp. Date 6/2/2016 ; Service Code 2K9138 , Lot Number 160670077C , Exp. Date 6/6/2016 ; Service Code 2K9138 , Lot Number 160730033C , Exp. Date 6/12/2016 ; Service Code 2K9138 , Lot Number 160770056C , Exp. Date 6/16/2016 ; Service Code 2K9138 , Lot Number 160880076C , Exp. Date 6/27/2016 ; Service Code 2K9138 , Lot Number 160910024C , Exp. Date 6/30/2016 ; Service Code 2K9138 , Lot Number 160950084C , Exp. Date 7/4/2016 ; Service Code 2K9138 , Lot Number 160960054C , Exp. Date 7/5/2016 ; Service Code 2T6257 , Lot Number 160450201M , Exp. Date 5/15/2016 ; Service Code 2T6257 , Lot Number 160620194M , Exp. Date 6/1/2016 ; Service Code 2T6257 , Lot Number 160810203M , Exp. Date 6/20/2016 ; Service Code 2T6257 , Lot Number 160820230M , Exp. Date 6/21/2016 ; Service Code 2T6257 , Lot Number 160870153M , Exp. Date 6/26/2016 ; Service Code 2T6257 , Lot Number 160880278M , Exp. Date 6/27/2016 ; Service Code 2T6257 , Lot Number 160950233M , Exp. Date 7/4/2016 ; Service Code 2T8141 , Lot Number 160450016C , Exp. Date 5/6/2016 ; Service Code 2T8141 , Lot Number 160520016C , Exp. Date 5/13/2016 ; Service Code 2T8141 , Lot Number 160530019C , Exp. Date 5/14/2016 ; Service Code 2T8141 , Lot Number 160590009C , Exp. Date 5/20/2016 ; Service Code 2T8141 , Lot Number 160670022C , Exp. Date 5/28/2016 ; Service Code 2T8141 , Lot Number 160730011C , Exp. Date 6/3/2016 ; Service Code 2T8141 , Lot Number 160740029C , Exp. Date 6/3/2016 ; Service Code 2T8141 , Lot Number 160800022C , Exp. Date 6/10/2016 ; Service Code 2T8141 , Lot Number 160870008C , Exp. Date 6/17/2016 ;
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.