NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 14...
FDA Drug Recall #D-0322-2022 — Class II — November 12, 2021
Recall Summary
| Recall Number | D-0322-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 12, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | SterRx, LLC |
| Location | Plattsburgh, NY |
| Product Type | Drugs |
| Quantity | 36,576 bags |
Product Description
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Lot / Code Information
S21082/BQV 13-Nov-21 S21102/BRM 28-Nov-21 S21135/BST 14-Dec-21 S21166/BTX 7-Jan-22 S21178/BUJ 28-Jan-22 S21226/BVZ 5-Feb-22 S21237/BWI 7-Feb-22 S21242/BWM 13-Feb-22 S21280/BXX 11-Mar-22 S21302/BYS 21-Mar-22 S21345/CAE 23-Apr-22 S21424/CDG 28-May-22
Other Recalls from SterRx, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0931-2023 | Class II | Norepinephrine 4 mg per 250 mL (16 mcg per mL) ... | Jul 7, 2023 |
| D-0932-2023 | Class II | Norepinephrine 8 mg per 250 mL (32 mcg per mL) ... | Jul 7, 2023 |
| D-0934-2023 | Class II | Norepinephrine 32 mg per 250 mL (128 mcg per mL... | Jul 7, 2023 |
| D-0930-2023 | Class II | Sodium Bicarbonate in 5% Dextrose Injection, 15... | Jul 7, 2023 |
| D-0933-2023 | Class II | Norepinephrine 16 mg per 250 mL (64 mcg per mL)... | Jul 7, 2023 |
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.