NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Vo...
FDA Drug Recall #D-0625-2020 - Class III, December 16, 2019
Recall Summary
| Recall Number | D-0625-2020 |
| Classification | Class III, Low risk |
| Date Initiated | December 16, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pharmedium Services, LLC |
| Location | Lake Forest, IL |
| Product Type | Drugs |
| Quantity | 5820 bags |
Product Description
NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Reason for Recall
Subpotent Drug
Distribution Pattern
Nationwide in the U.S.
Lot / Code Information
Lot #s: 192930039S Exp. 12/18/19; 192930041S Exp. 12/18/19; 192940048S Exp. 12/19/19; 192940049S Exp. 12/19/19; 192950031S Exp. 12/20/19; 192950032S Exp. 12/20/19; 192960039S Exp. 12/22/19; 192960040S Exp. 12/22/19; 192960041S Exp. 12/22/19; 192960042S Exp. 12/22/19; 192970034S Exp. 12/22/19; 192970036S Exp. 12/22/19; 192970037S Exp. 12/22/19; 192980043S Exp. 12/25/19; 192980044S Exp. 12/25/19; 192980045S Exp. 12/25/19; 193010042S Exp. 12/26/19; 193020042S Exp. 12/27/19; 193030039S Exp. 12/28/19; 193030040S Exp. 12/28/19; 193030049S Exp. 12/28/19; 193040045S Exp. 12/29/19; 193040046S Exp. 12/29/19; 193040047S Exp. 12/29/19; 193080040S Exp. 1/2/20; 193080041S Exp. 1/2/20; 193080042S Exp. 1/2/20; 193080043S Exp. 1/2/20; 193080044S Exp. 1/2/20; 193090034S Exp. 1/3/20; 193090035S Exp. 1/3/20; 193090036S Exp. 1/3/20; 193100041S Exp. 1/4/20; 193100042S Exp. 1/4/20; 193100043S Exp. 1/4/20; 193120036S Exp. 1/8/20; 193150028S Exp. 1/9/20; 193170033S Exp. 1/11/20; 193170034S Exp. 1/11/20; 193170035S Exp. 1/11/20; 193180035S Exp. 1/12/20; 193190035S Exp. 1/15/20; 193190038S Exp. 1/15/20; 193220038S Exp. 1/16/20; 193230037S Exp. 1/17/20; 193240029S Exp. 1/18/20; 193240030S Exp. 1/18/20; 193240031S Exp. 1/18/20; 193250028S Exp. 1/19/20; 193360031S Exp. 1/30/20
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
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping, abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
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.