Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply
FDA Drug Recall #D-0768-2018 — Class II — April 3, 2018
Recall Summary
| Recall Number | D-0768-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 3, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Kroger Specialty Pharmacy, Inc. |
| Location | Vicksburg, MS |
| Product Type | Drugs |
| Quantity | Unknown |
Product Description
Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply
Reason for Recall
Lack of Processing Controls.
Distribution Pattern
MS, LA, AR, IL, FL
Lot / Code Information
All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Other Recalls from Kroger Specialty Pharmacy, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0796-2018 | Class II | Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply | Apr 3, 2018 |
| D-0782-2018 | Class II | Gleevec 100 mg tablet NDC 00078-0401-34 30 days... | Apr 3, 2018 |
| D-0751-2018 | Class II | Orkambi 100 mg/125 mg Tablets #112 NDC 51167-07... | Apr 3, 2018 |
| D-0766-2018 | Class II | Copaxone 20 mg Injection PFS (30) NDC 68546-031... | Apr 3, 2018 |
| D-0797-2018 | Class II | Tasigna Capsules 150 mg NDC 00078-0592-87 28 da... | Apr 3, 2018 |
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.