CLOMIPHENE CITRATE Recall D-1041-2022
Description: ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55
CLOMIPHENE CITRATE Recall D-1041-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1041-2022 |
| Event ID | 89646 |
| Brand | CLOMIPHENE CITRATE |
| Generic Name | CLOMIPHENE CITRATE |
| Manufacturer | CLOMIPHENE CITRATE |
| Original Package? | 1 |
| Active Substance | CLOMIPHENE CITRATE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 240 cartons/3 blister packs per carton |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 49884-701 |
| Drug UPC | 0349884701543 0349884701550 0349884701529 |
| 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 | 1B8447E7YI |
| Drug Application Number | ANDA075528 |
| Structured Product Labeling (SPL ID) | a381820e-898a-4a49-83e6-a243a3d99750 |
| Structured Product Labeling (SPL Set ID) | be399623-6400-475d-93d3-1dedd4d43017 |
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