Agency classClass IIOur severity:Severe FDA (Drugs)·D-1478-2015·Announced 2015-09-23

Estradiol Valerate Injectable Vials Recalled for Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Estradiol Valerate 20 mg/ml injectable vials 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 failures in injectable products are categorized as Severe (Score 4) due to the risk of infection or other significant health consequences.

Plain-English summary

The Compounding Pharmacy of America is recalling Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vials. The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility assurance.

The affected product is a sterile, room-temperature injectable solution with a total volume of 12 ml. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes identified in the recall include 11262014@56, 01262015@16, 01302015@51, and 03272015@41.

Patients who have received this medication should consult their healthcare provider for guidance on next steps. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product: Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Sterile
Hazard: sterility-failure
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 (9)

All lots distributed between November 2014 and May 2015
11262014@56
5/25/2015
01262015@16
7/25/2015
01302015@51
7/29/2015
03272015@41
9/23/2015

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

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Same hazard · sterility failure