Agency classClass IIOur severity:Severe FDA (Drugs)·D-1637-2015·Announced 2015-09-23

Sufentanil Solution Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Sufentanil 50 mcg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.

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. Per the rubric, FDA Class II recalls involving potential sterility issues in injectable medications are categorized as Severe (Score 4) due to the risk of serious injury or hospitalization from non-sterile products.

Plain-English summary

The Compounding Pharmacy of America is recalling Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free. The recall was initiated following an FDA inspection that identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product.

The affected product is distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the official recall documentation.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on disposal or replacement. The FDA classifies this recall as Class II, indicating a reasonable probability that temporary or medically reversible adverse health consequences may occur.

The recalled product

Product: Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Solution
Hazard: sterility
gmp-violation

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 (13)

All lots distributed between November 2014 and May 2015
03112015@2
6/9/2015
03162015@6/14/2015
03242015@2
6/22/2015
03302015@62
6/28/2015
0406201@43
7/5/2015
04142015@62
7/13/2015
04122015@6/20/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 382 recalled by The Compounding Pharmacy of America 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 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

See all →

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Same hazard · sterility