buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carto...
FDA Drug Recall #D-001-2013 — Class III — March 29, 2012
Recall Summary
| Recall Number | D-001-2013 |
| Classification | Class III — Low risk |
| Date Initiated | March 29, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | McKesson Packaging Services |
| Location | Concord, NC |
| Product Type | Drugs |
| Quantity | 187 cartons |
Product Description
buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, carton barcode 6373944910.
Reason for Recall
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Distribution Pattern
Nationwide
Lot / Code Information
Lot #: 0074583, Exp. Date 03/12
Other Recalls from McKesson Packaging Services
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0716-2018 | Class III | Diltiazem HCl Extended-Release Capsules, USP 24... | Apr 23, 2018 |
| D-0715-2018 | Class III | Diltiazem CD (Diltiazem Hydrochloride Extended-... | Apr 23, 2018 |
| D-0714-2018 | Class III | Diltiazem HCl Extended-Release Capsules, USP 12... | 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 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.