Beacon Hill Medical Pharmacy Recalls Procaine Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Procaine P/F 20 mg/ml injectable because FDA inspections raised concerns about sterility assurance and quality control.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a sterile injectable product with sterility assurance concerns, which poses a risk of serious injury or death if contaminated, meeting the criteria for a Severe rating.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling Procaine P/F 20 mg/ml injectable, all presentations, for intravenous and subcutaneous use only. The product was compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, MI, and distributed nationwide in the USA.
The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- PROCAINE P/F 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Manufacturer
- Beacon Hill Medical Pharmacy, P.C.
- Category
- Drug — Injectable
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)
- 06132013@30
- 06272013@27
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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