Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) ...
FDA Drug Recall #D-0179-2021 - Class II, December 17, 2020
Recall Summary
| Recall Number | D-0179-2021 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 17, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ascend Laboratories LLC |
| Location | Parsippany, NJ |
| Product Type | Drugs |
| Quantity | 9,524 bottles |
Product Description
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68
Reason for Recall
Failed Impurity/Degradation Specifications
Distribution Pattern
Nationwide
Lot / Code Information
20141680, 20141681, 20141759
Other Recalls from Ascend Laboratories LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0229-2022 | Class II | Cefixime Capsules 400 mg, 50 capsules bottles, ... | Nov 3, 2021 |
| D-0392-2021 | Class III | Olmesartan Medoxomil Tablets, USP, 20 mg, Rx On... | Apr 29, 2021 |
| D-0264-2021 | Class II | Cephalexin for Oral Suspension, USP 250 mg per ... | Jan 22, 2021 |
| D-0263-2021 | Class II | Cephalexin for Oral Suspension, USP 250 mg per ... | Jan 22, 2021 |
| D-0178-2021 | Class II | Ascend Laboratories, llc Cephalexin for Oral Su... | Dec 17, 2020 |
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.