Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablet USP
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Oxybutynin Chloride Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Wrong bar code
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50
Affected NDC
10702-0201-50
Compare with the code on your package — it is the most precise check available.
Drug: Oxybutynin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Oxybutynin Chloride NDC 10702-0201 |
5 mg/1 | Tablet Oral |
KVK-Tech, Inc. | Rx |
- Recalling firm
- KVK-Tech, Inc.
- NDC code
- 10702-201-50
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0340-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Oxybutynin recalls
See all
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablet USP
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablet USP
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Failed Dissolution Specifications
Class III · Low risk
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Failed Dissolution Specifications
Other recalls by KVK-Tech, Inc.
All 2018 recalls
Class II · Moderate risk
Phentermine Hydrochloride Capsules
cGMP deviations
Class II · Moderate risk
Indomethacin Extended-Release Capsules USP
cGMP deviations
Class I · High risk
Betaxolol Tablets
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
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