ClomiPHENE Citrate Tablets 50 mg Recalled Due to Temperature Abuse
McKesson Medical-Surgical is recalling ClomiPHENE Citrate Tablets 50 mg due to temperature abuse during distribution. The medication was distributed nationwide; patients should contact their healthcare provider for guidance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves cGMP deviations related to temperature abuse, a manufacturing and handling process deviation. No illnesses or injuries have been reported in the source material. Per the severity rubric, recalls without reported incidents where the hazard is theoretical are rated at most 3 (High).
Plain-English summary
McKesson Medical-Surgical Inc. is recalling ClomiPHENE Citrate Tablets, USP 50 mg (NDC 49884-701-55), 30-count bottles manufactured by PAR Pharma. The recall affects 240 cartons, each containing 3 blister packs. The recall was initiated due to cGMP deviations involving temperature abuse during distribution.
The recalled product was distributed nationwide to healthcare facilities and pharmacies. McKesson Medical-Surgical is unable to identify the specific lot numbers associated with individual consignees; each customer notification letter specifies the dates the product may have been shipped to that facility.
Patients who have this medication should contact their healthcare provider or pharmacy if they believe they may have received recalled product. Healthcare providers and pharmacies should quarantine any remaining affected product and follow the instructions provided in their recall notification from McKesson Medical-Surgical.
This Class II recall is being overseen by the U.S. Food and Drug Administration.
The recalled product
- Product
- ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
- Hazard
- temperature-abuse
Distribution
Distributed nationwide across the United States.
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