5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;...
FDA Drug Recall #D-1424-2016 — Class II — May 5, 2016
Recall Summary
| Recall Number | D-1424-2016 |
| 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 | 562 bags |
Product Description
5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), 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 2H8287 , Lot Number 160390110M , Exp. Date 5/9/2016 ; Service Code 2H8287 , Lot Number 160450123M , Exp. Date 5/15/2016 ; Service Code 2H8287 , Lot Number 160470115M , Exp. Date 5/17/2016 ; Service Code 2H8287 , Lot Number 160600178M , Exp. Date 5/30/2016 ; Service Code 2H8287 , Lot Number 160750128M , Exp. Date 6/14/2016 ; Service Code 2H8287 , Lot Number 160800058M , Exp. Date 6/18/2016 ; Service Code 2H8287 , Lot Number 160820110M , Exp. Date 6/20/2016 ; Service Code 2H8287 , Lot Number 160960130M , Exp. Date 7/5/2016 ; Service Code 2H8287 , Lot Number 160970119M , Exp. Date 7/6/2016 ; Service Code 2K8287 , Lot Number 160530140M , Exp. Date 5/17/2016 ; Service Code 2K8287 , Lot Number 160630194M , Exp. Date 5/27/2016 ; Service Code 2K8287 , Lot Number 160680251M , Exp. Date 6/1/2016 ; Service Code 2K8287 , Lot Number 160760045M , Exp. Date 6/8/2016 ; Service Code 2K8287 , Lot Number 160770044M , Exp. Date 6/9/2016 ; Service Code 2K8287 , Lot Number 160770117M , Exp. Date 6/10/2016 ; Service Code 2K8287 , Lot Number 160940055M , Exp. Date 6/26/2016 ; Service Code 2K8287 , Lot Number 160960048M , Exp. Date 6/28/2016 ; Service Code 2K8811 , Lot Number 160490167M , Exp. Date 5/9/2016 ; Service Code 2K8811 , Lot Number 160530310M , Exp. Date 5/14/2016 ; Service Code 2K8811 , Lot Number 160600078M , Exp. Date 5/20/2016 ; Service Code 2K8811 , Lot Number 160630029M , Exp. Date 5/23/2016 ; Service Code 2K8811 , Lot Number 160670255M , Exp. Date 5/28/2016 ; Service Code 2K8811 , Lot Number 160750239M , Exp. Date 6/5/2016 ; Service Code 2K8811 , Lot Number 160810296M , Exp. Date 6/11/2016 ; Service Code 2K8811 , Lot Number 160950247M , Exp. Date 6/25/2016 ; Service Code 2K8873 , Lot Number 160680043C , Exp. Date 5/29/2016 ; Service Code 2K8873 , Lot Number 160840036C , Exp. Date 6/14/2016 ; Service Code 2K8873 , Lot Number 160870015C , Exp. Date 6/17/2016 ; Service Code 2K8873 , Lot Number 160960052C , Exp. Date 6/26/2016 ;
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.