QM-4 Compounded Injectable Recalled for Manufacturing Control Deviations
Olympia Compounding Pharmacy is recalling QM-4, a compounded injectable, for manufacturing control deviations. Environmental and personnel monitoring excursions were not properly investigated prior to October 2021.
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 is an FDA Class II recall for manufacturing control deviations. No illnesses or injuries have been reported. The theoretical risk stems from improper investigation of environmental and personnel monitoring excursions in a compounded injectable product.
Plain-English summary
Olympia Compounding Pharmacy is recalling 1,647 vials of QM-4, a compounded injectable medication (containing Papaverine, Phentolamine, Alprostadil, and Atropine), distributed nationwide. The FDA classified this as a Class II recall.
The recall is due to manufacturing practice deviations. Prior to October 1, 2021, the pharmacy failed to properly investigate excursions in environmental and personnel monitoring that exceeded established action limits.
Two lots are affected: E41027 (May 27, 2022 expiration) and I24E13 (September 13, 2022 expiration). Patients and healthcare providers should stop using doses from these lots and contact their pharmacist or physician.
The recalled product
- Product
- QM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0020-10.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: E41027 BUD: 5/27/2022
- I24E13 BUD: 9/13/2022
Distribution
Distributed nationwide across the United States.
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