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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