Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufact...
FDA Drug Recall #D-1527-2016 — Class III — September 15, 2016
Recall Summary
| Recall Number | D-1527-2016 |
| Classification | Class III — Low risk |
| Date Initiated | September 15, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mckesson Packaging Services |
| Location | Concord, NC |
| Product Type | Drugs |
| Quantity | 3,492 unit cartons of 10 x 10 blister cards |
Product Description
Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10
Reason for Recall
Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
Distribution Pattern
CO, IL, LA, OH
Lot / Code Information
Lot #: 0111512; Exp. 08/17
Other Recalls from Mckesson Packaging Services
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0714-2018 | Class III | Diltiazem HCl Extended-Release Capsules, USP 12... | Apr 23, 2018 |
| D-0715-2018 | Class III | Diltiazem CD (Diltiazem Hydrochloride Extended-... | Apr 23, 2018 |
| D-0716-2018 | Class III | Diltiazem HCl Extended-Release Capsules, USP 24... | Apr 23, 2018 |
| D-0914-2018 | Class II | RANITIDINE Tablets, USP 150 mg UD 100 tablets (... | Feb 26, 2018 |
| D-0338-2018 | Class III | Megestrol Acetate Oral Suspension, USP 400 mg/ ... | Jan 29, 2018 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced 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.