Agency classClass IIOur severity:Severe FDA (Drugs)·D-1626-2015·Announced 2015-09-23

Progesterone Injection Recalled for Lack of Sterility Assurance

The Compounding Pharmacy of America is recalling Progesterone 100 mg/ml Injection due to FDA inspection findings of GMP violations that 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable drugs are classified as Severe (Score 4), particularly when structural or quality defects are identified by inspection.

Plain-English summary

The Compounding Pharmacy of America is recalling 18 ml multi-dose vials of Progesterone 100 mg/ml Injection, sterile, room temperature. The recall covers all lots distributed between November 2014 and May 2015, including lot 04292015@66. The product was distributed nationwide.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The specific hazard is a lack of assurance of sterility.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product: Progesterone 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Sterile
Hazard: lack-of-sterility
gmp-violations

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 (3)

All lots distributed between November 2014 and May 2015
04292015@66
10/26/2015

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 · lack of sterility