LABETALOL HYDROCHLORIDE Recall D-1094-2022
Description: Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01
LABETALOL HYDROCHLORIDE Recall D-1094-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1094-2022 |
| Event ID | 89646 |
| Brand | LABETALOL HCL |
| Generic Name | LABETALOL HYDROCHLORIDE |
| Manufacturer | LABETALOL HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | LABETALOL HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 1 bottle/100 tablets |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 49884-122 49884-123 49884-124 |
| Drug UPC | 0349884122058 0349884123055 0349884124052 |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 1GEV3BAW9J |
| Drug Application Number | ANDA200908 |
| Structured Product Labeling (SPL ID) | c2fd5bf2-ce6b-48a7-a782-17dd1df2d326 |
| Structured Product Labeling (SPL Set ID) | 56ab2ff4-14a6-4297-afd8-56b92e1f64a0 |
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