BETAXOLOL HYDROCHLORIDE Recall D-0049-2024
Description: 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.
BETAXOLOL HYDROCHLORIDE Recall D-0049-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0049-2024 |
| Event ID | 93101 |
| Brand | BETAXOLOL HYDROCHLORIDE |
| Generic Name | BETAXOLOL HYDROCHLORIDE |
| Manufacturer | BETAXOLOL HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | BETAXOLOL HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA and PR |
| Quantity | 1488 bottles |
| Recall Reason | Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles. |
| Drug Classification | Class I |
| Drug Code Info | 20231025 |
| Product NDC | 10702-013 10702-014 |
| Recall Initiation Date | 20230920 |
| Report Date | 20231025 |
| Classification Date | 20231018 |
| Address | 110 Terry Dr Newtown, PA 18940-3427 United States |
| Recalling Firm | KVK-Tech, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 6X97D2XT0O |
| Drug Application Number | ANDA078962 |
| Structured Product Labeling (SPL ID) | b3b383a4-88cf-7aed-e053-2995a90ab5c4 |
| Structured Product Labeling (SPL Set ID) | f3b50bbb-df03-4ed7-9d8d-180edc2abd54 |
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