K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Efferve...
FDA Drug Recall #D-1036-2013 — Class II — August 8, 2013
Recall Summary
| Recall Number | D-1036-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 8, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Qualitest Pharmaceuticals |
| Location | Huntsville, AL |
| Product Type | Drugs |
| Quantity | 1680 boxes |
Product Description
K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral Solution, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook, CT 06409
Reason for Recall
LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Distribution Pattern
Natiowide
Lot / Code Information
Lot Number 21230-2, Exp. DEC 2015
Other Recalls from Qualitest Pharmaceuticals
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1405-2015 | Class III | ALLOPURINOL TABLETS, USP, 300 mg, 500 count bot... | Jul 20, 2015 |
| D-1239-2015 | Class III | HydrOXYzine Hydrochloride Tablets, USP 25 mg, ... | Jun 29, 2015 |
| D1151-2015 | Class III | Disulfiram tablets, USP, 500 mg, 100-count bott... | Jun 18, 2015 |
| D00432-2015 | Class III | PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml c... | Mar 25, 2015 |
| D-0411-2015 | Class II | PROMETHAZINE DM SYRUP (Promethazine Hydrochlori... | Feb 23, 2015 |
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.