20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chlorid...
FDA Drug Recall #D-1412-2016 — Class II — May 5, 2016
Recall Summary
| Recall Number | D-1412-2016 |
| 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 | 555 Medical Cassettes |
Product Description
20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48
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 2K8158 , Lot Number 160380113M , Exp. Date 5/8/2016 ; Service Code 2K8158 , Lot Number 160410115M , Exp. Date 5/11/2016 ; Service Code 2K8158 , Lot Number 160420111M , Exp. Date 5/12/2016 ; Service Code 2K8158 , Lot Number 160450184M , Exp. Date 5/15/2016 ; Service Code 2K8158 , Lot Number 160520106M , Exp. Date 5/21/2016 ; Service Code 2K8158 , Lot Number 160530143M , Exp. Date 5/23/2016 ; Service Code 2K8158 , Lot Number 160550124M , Exp. Date 5/25/2016 ; Service Code 2K8158 , Lot Number 160560211M , Exp. Date 5/26/2016 ; Service Code 2K8158 , Lot Number 160600195M , Exp. Date 5/30/2016 ; Service Code 2K8158 , Lot Number 160620137M , Exp. Date 6/1/2016 ; Service Code 2K8158 , Lot Number 160690124M , Exp. Date 6/7/2016 ; Service Code 2K8158 , Lot Number 160730219M , Exp. Date 6/12/2016 ; Service Code 2K8158 , Lot Number 160740084C , Exp. Date 6/14/2016 ; Service Code 2K8158 , Lot Number 160770123M , Exp. Date 6/16/2016 ; Service Code 2K8158 , Lot Number 160840027M , Exp. Date 6/22/2016 ; Service Code 2K8158 , Lot Number 160870228M , Exp. Date 6/26/2016 ; Service Code 2K8158 , Lot Number 160910212M , Exp. Date 6/30/2016 ; Service Code 2K8158 , Lot Number 161080220M , Exp. Date 7/17/2016 ; Service Code 2K8495 , Lot Number 160420155M , Exp. Date 5/12/2016 ; Service Code 2K8495 , Lot Number 160490122M , Exp. Date 5/19/2016 ; Service Code 2K8913 , Lot Number 160940019C , Exp. Date 5/10/2016 ; Service Code 2K8913 , Lot Number 160960022C , Exp. Date 5/12/2016 ; Service Code 2K8913 , Lot Number 160970021C , Exp. Date 5/13/2016 ; Service Code 2K8947 , Lot Number 160970025C , Exp. Date 5/17/2016 ; Service Code 2K8986 , Lot Number 160910040M , Exp. Date 5/11/2016 ; Service Code 2T6622 , Lot Number 160950152M , Exp. Date 5/10/2016 ; Service Code 2K8495 , Lot Number 160520175M , Exp. Date 5/22/2016 ; Service Code 2K8495 , Lot Number 160530128M , Exp. Date 5/23/2016 ; Service Code 2K8495 , Lot Number 160540117M , Exp. Date 5/24/2016 ; Service Code 2K8495 , Lot Number 160550130M , Exp. Date 5/25/2016 ; Service Code 2K8495 , Lot Number 160560135M , Exp. Date 5/26/2016 ; Service Code 2K8495 , Lot Number 160610198M , Exp. Date 5/31/2016 ; Service Code 2K8495 , Lot Number 160740237M , Exp. Date 6/13/2016 ; Service Code 2K8495 , Lot Number 160750177M , Exp. Date 6/14/2016 ; Service Code 2K8495 , Lot Number 160760001M , Exp. Date 6/14/2016 ; Service Code 2K8495 , Lot Number 160820228M , Exp. Date 6/21/2016 ; Service Code 2K8495 , Lot Number 160890173M , Exp. Date 6/28/2016 ;
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.