FDA Recalls PGE Injectable Due to Sterility Assurance Concerns
The Compounding Center at Blue Ridge is recalling PGE 20 mcg/mL and 40 mcg/mL injectables due to quality control concerns regarding sterility assurance identified during an FDA inspection.
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 lack of assurance of sterility in injectable products, which poses a significant risk of serious injury or death if contaminated, meeting the criteria for a Severe rating.
Plain-English summary
The Compounding Center at Blue Ridge is recalling PGE 20 mcg/mL Injectable (10 mL) and PGE 40 mcg/mL Injectable (5 mL). The recall covers all lots of sterile products compounded by the pharmacy within their expiry dates. The affected units were distributed in North Carolina.
The recall was initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Specifically, the agency cited a lack of assurance of sterility for the compounded products.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
- Manufacturer
- Compounding Centre At Blue Ridge
- Category
- Drug — Injectable
- Affected units
- 11
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 (1)
- All Lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Compounding Centre At Blue Ridge 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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