Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By...
FDA Drug Recall #D-1446-2014 — Class I — September 27, 2011
Recall Summary
| Recall Number | D-1446-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | September 27, 2011 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Shamrock Medical Solutions Group LLC |
| Location | Lewis Center, OH |
| Product Type | Drugs |
| Quantity | 89/120 mg tablets |
Product Description
Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90
Reason for Recall
Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules
Distribution Pattern
Product was shipped to the following states: CO, MA, OH, TX & WY.
Lot / Code Information
Use By: 5/31/2013, Lot: 0021OC, NDC 62037-0696-90
Other Recalls from Shamrock Medical Solutions Group LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1448-2014 | Class I | metFORMIN ER Tablets, 500 mg, Rx, Packaged and ... | Sep 27, 2011 |
| D-1451-2014 | Class II | Docusate Calcium Softgel Capsules, 240 mg, OTC,... | Sep 27, 2011 |
| D-1447-2014 | Class I | Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C... | Sep 27, 2011 |
| D-1450-2014 | Class II | Sulfamethoxazole and Trimethoprim Tablets, 800 ... | Sep 27, 2011 |
| D-1449-2014 | Class II | Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx... | Sep 27, 2011 |
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.