The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-402-2014·Announced 2014-01-15

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard
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.

See all 5 products in this recall →

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