CALCITONIN SALMON Recall D-0475-2023
Description: Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11.
CALCITONIN SALMON Recall D-0475-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0475-2023 |
| Event ID | 91802 |
| Brand | CALCITONIN SALMON |
| Generic Name | CALCITONIN SALMON |
| Manufacturer | CALCITONIN SALMON |
| Original Package? | 1 |
| Active Substance | CALCITONIN SALMON |
| Drug Route | NASAL |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 372,938 bottles |
| Recall Reason | Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay. |
| Drug Classification | Class II |
| Drug Code Info | 20230405 |
| Product NDC | 49884-161 |
| Product NUI | M0003145 N0000175942 |
| Pharma Class (EPC) | Calcitonin [EPC] |
| Pharma Class (CS) | Calcitonin [CS] |
| Recall Initiation Date | 20230302 |
| Report Date | 20230405 |
| Classification Date | 20230324 |
| Address | 1400 Atwater Dr Malvern, PA 19355-8701 United States |
| Recalling Firm | Endo Pharmaceuticals, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Unique Ingredient Identifier | 7SFC6U2VI5 |
| Drug Application Number | ANDA076979 |
| Structured Product Labeling (SPL ID) | 01b710fc-1c96-4e2b-95fe-af53c5966b90 |
| Structured Product Labeling (SPL Set ID) | a6eaedb3-5c96-4859-be43-a48c9c818bc7 |
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