Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Chemical contamination; presence of lead and lithium above specification
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Reason Lack of Assurance of Sterility
Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Reason Subpotent drug
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