Class II · Moderate risk
Betaxolol Ophthalmic Solution
CGMP Deviations:
Betaxolol Tablets (Betaxolol Hydrochloride)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
Affected NDC
10702-0013-01
Compare with the code on your package — it is the most precise check available.
Drug: Betaxolol
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 |
|---|---|---|---|---|
| Betaxolol Hydrochloride NDC 10702-0013 |
10 mg/1 | Tablet, Coated Oral |
Kvk-Tech, INC. | Rx |
- Recalling firm
- KVK-Tech, Inc.
- NDC code
- 10702-013-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Sep 29, 2023 · FDA notice with lot numbers
- FDA recall number
- D-0049-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Betaxolol recalls
See all
Class II · Moderate risk
Betaxolol Ophthalmic Solution
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Other recalls by KVK-Tech, Inc.
All 2023 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
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class III · Low risk
Hydrocodone Bitartrate and Homatropine Methlybromide tablets
Failed Impurities/Degradation Specifications
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.