Agency classClass IIOur severity:Severe FDA (Drugs)·D-1450-2015·Announced 2015-09-23

Cholecalciferol Injectable Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Cholecalciferol 50,000 IU/ml Injectable vials because FDA inspections identified 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly given the risk of sterility failure in an injectable product.

Plain-English summary

The Compounding Pharmacy of America is recalling Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate. The product is distributed nationwide and consists of 102 mL total volume vials. The recall covers all lots distributed between November 2014 and May 2015, including specific lot codes 03202015@26, 04282015@1, and 05042015@53.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should stop using the affected product. Consumers should contact their healthcare provider or the recalling firm for further instructions on how to handle or return the medication.

The recalled product

Product: Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
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 (7)

All lots distributed between November 2014 and May 2015
03202015@26
6/18/2015
04282015@1
7/27/2015
05042015@53
8/2/2015

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