Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles,...
FDA Drug Recall #D-0715-2018 — Class III — April 23, 2018
Recall Summary
| Recall Number | D-0715-2018 |
| Classification | Class III — Low risk |
| Date Initiated | April 23, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mckesson Packaging Services |
| Location | Concord, NC |
| Product Type | Drugs |
| Quantity | 7656 cartons |
Product Description
Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10
Reason for Recall
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Distribution Pattern
Nationwide with the US
Lot / Code Information
Lot #: 0114214, Exp. 09/2018
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-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 |
| D-1128-2017 | Class III | Propafenone Hydrochloride tablets, 150 mg, pack... | Aug 28, 2017 |
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.