GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (...
FDA Drug Recall #D-0520-2017 — Class II — February 3, 2017
Recall Summary
| Recall Number | D-0520-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 3, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Amerisource Health Services |
| Location | Columbus, OH |
| Product Type | Drugs |
| Quantity | 19,393 cartons (581,790 extended release tablets) |
Product Description
GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21
Reason for Recall
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Distribution Pattern
Nationwide
Lot / Code Information
Lot #160133, 160549 Exp. 08/17 Lot #162006; Exp. 09/17 Lot #163348A, 163348B; Exp. 10/17
Other Recalls from Amerisource Health Services
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0091-2018 | Class II | Paroxetine Tablets, USP, 30mg, 100 tablets (10 ... | Oct 24, 2017 |
| D-0074-2018 | Class III | Enalapril Maleate Tablets, USP, 5 mg, 100 Table... | Aug 29, 2017 |
| D-0490-2017 | Class II | CycloSPORINE Capsules, USP, 100 mg, 30 count (5... | Feb 8, 2017 |
| D-0137-2017 | Class III | Bupropion Hydrochloride Extended-Release Tablet... | Oct 27, 2016 |
| D-0144-2017 | Class III | AHP NIFEdipine Capsules, 10mg USP, 100 count ca... | Oct 13, 2016 |
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.