QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800
Assurance Infusion recalled QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800 under a Class II classification, reported 20200122. Current status: Terminated.
- Recall number
- D-0763-2020
- Recalling firm
- Assurance Infusion
- Classification
- Class II
- Status
- Terminated
- Report date
- 20200122
- Initiation date
- 20191220
- Termination date
- 20211027
Reason for recall
Lack of sterility assurance.
Product description
QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800
What Class II means
Class I is the most serious FDA recall category. It means there is a reasonable probability that using the product will cause serious adverse health consequences or death.
Current status
This recall has been terminated by the FDA, meaning the agency considers the action no longer necessary.
What to do if you have this product
If you hold this product, stop using it as directed by the recall notice and contact the pharmacy or prescriber that supplied it for a replacement or for disposal instructions. Do not rely on this page alone: confirm lot numbers against the official FDA enforcement report before taking action.
Other recalls by Assurance Infusion
| Recall | Product | Classification | Status | Reported |
|---|---|---|---|---|
| D-0666-2020 | BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Class II | Terminated | 20200122 |
| D-0754-2020 | MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Class II | Terminated | 20200122 |
| D-0680-2020 | BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Class II | Terminated | 20200122 |
| D-0743-2020 | HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Class II | Terminated | 20200122 |
| D-0739-2020 | HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Class II | Terminated | 20200122 |
| D-0749-2020 | LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800 | Class II | Terminated | 20200122 |
Recent Class II recalls
| Recall | Product | Firm | Status | Reported |
|---|---|---|---|---|
| D-0022-2027 | Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936, | Carolina Infusion, LLC | Ongoing | 20261014 |
| D-0023-2027 | Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936, | Carolina Infusion, LLC | Ongoing | 20261014 |
| D-0006-2027 | Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Crocodile Tears, Palm Beach Gardens, FL 33410, UPC: 8 67166 00000 4; c) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01156 6; d) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 05620 6; e) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., 1295 Towbin Ave., Lakewood, NJ 08701, NDC 57896-181-05; f) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71303 2; h) Foster & Thrive, Distributed by: McKesson Corp. Via Strategic Sourcing Servies LLC., Memphis, TN 38141, NDC 70677-1157-1; I) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3. | K.C. Pharmaceuticals, Inc. | Ongoing | 20261014 |
| D-0027-2027 | TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 | Carolina Infusion, LLC | Ongoing | 20261014 |
| D-0021-2027 | QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 | Carolina Infusion, LLC | Ongoing | 20261014 |
| D-0025-2027 | Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 | Carolina Infusion, LLC | Ongoing | 20261014 |
Frequently asked questions
What product is affected by recall D-0763-2020?
QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800 The recalling firm is Assurance Infusion.
How serious is a Class II recall?
Class I is the most serious FDA recall category. It means there is a reasonable probability that using the product will cause serious adverse health consequences or death.
What should I do with the recalled product?
Stop using it, check the lot number against the official notice, and return it or ask your pharmacy how to dispose of it. Speak to a healthcare professional if you have already used it and feel unwell.
Recall records are reproduced from the FDA enforcement report. Always confirm lot numbers and current guidance with the FDA or the recalling firm before acting.