Agency classClass IIOur severity:Severe FDA (Drugs)·D-1532-2015·Announced 2015-09-23

HCG Injection Recalled for Lack of Sterility Assurance

The Compounding Pharmacy of America is recalling HCG 1,200 IU/ml Injection vials 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

The Compounding Pharmacy of America is recalling HCG 1,200 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.

The affected product is a 28 ml total volume multi-dose vial. All lots distributed between November 2014 and May 2015 are included in this recall. Specific lot codes identified in the recall include 03272015@22, 04062015@19, 04212015@39, and 04222015@62. The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product: HCG 1,200 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Medication
Hazard: 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 (9)

All lots distributed between November 2014 and May 2015
03272015@22
5/26/2015
04062015@19
6/5/2015
04212015@39
6/20/2015
04222015@62
6/21/2015

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