IPRATROPIUM BROMIDE Recall D-1040-2022
Description: Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25-count box (25 x 2.5 mL sterile unit-dose vials), Rx only, MFG: Nephron Pharma, NDC 0487-9801-25
IPRATROPIUM BROMIDE Recall D-1040-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1040-2022 |
| Event ID | 89646 |
| Brand | IPRATROPIUM BROMIDE |
| Generic Name | IPRATROPIUM BROMIDE |
| Manufacturer | IPRATROPIUM BROMIDE |
| Original Package? | 1 |
| Active Substance | IPRATROPIUM BROMIDE |
| Drug Route | RESPIRATORY (INHALATION) |
| Distribution | USA nationwide. |
| Quantity | 57 pouches |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0487-9801 |
| Drug UPC | 0304879801011 |
| 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 | J697UZ2A9J |
| Drug Application Number | ANDA075562 |
| Structured Product Labeling (SPL ID) | b8a6d890-6561-40e9-e053-2a95a90a0d61 |
| Structured Product Labeling (SPL Set ID) | db8095db-d1fd-4099-9fb1-d1ad4e284976 |
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