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.
Reported: April 5, 2023 Initiated: March 2, 2023 #D-0475-2023
Product 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.
Reason for Recall
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.
Details
- Recalling Firm
- Endo Pharmaceuticals, Inc.
- Units Affected
- 372,938 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Endo Pharmaceuticals, Inc.. Units affected: 372,938 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 5, 2023. Severity: Moderate. Recall number: D-0475-2023.
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