Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pa...
FDA Drug Recall #D-0360-2022 - Class II, December 29, 2021
Recall Summary
| Recall Number | D-0360-2022 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 29, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | RemedyRepack Inc. |
| Location | Indiana, PA |
| Product Type | Drugs |
| Quantity | a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules |
Product Description
Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Product was distributed to two direct accounts in MI and PA.
Lot / Code Information
Lot #: a) B1429436-110821, Exp 07/2022; B1429434-110821, Exp 11/2022; B1429435-110821, Exp 11/2022; B1279449-072021, Exp 07/2022; B1279457-072021, Exp 07/2022; B1279442-072021,Exp 07/2022; B1057718-012621, Exp 01/2022; B1057727-012621, Exp 01/2022; b) B1358139-092121, Exp 03/2022; B1424654-110421, B1437578-111421, Exp 05/2022
Other Recalls from RemedyRepack Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0411-2025 | Class II | Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsul... | Apr 22, 2025 |
| D-0378-2025 | Class II | Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsul... | Mar 24, 2025 |
| D-0217-2025 | Class II | Carvedilol 25 mg Tablet, QTY: 30 Tablets per Bl... | Jan 24, 2025 |
| D-0165-2025 | Class II | Duloxetine Delayed-Release Capsules, 60 mg, a) ... | Dec 2, 2024 |
| D-0611-2024 | Class II | Potassium Chloride Micro 10mEq K (750 mg) Exten... | Jun 26, 2024 |
Frequently Asked Questions
Nitrosamines are probable human carcinogens, they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.
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.