Agency classClass IIOur severity:Severe FDA (Drugs)·D-1667-2015·Announced 2015-09-23

Buckshot Injectable Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Buckshot Injectable 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 significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the potential loss of sterility in an injectable product represents a significant risk of adverse health consequences, fitting the Severe criteria for high-risk product hazards.

Plain-English summary

The Compounding Pharmacy of America is recalling Buckshot Injectable, a multi-dose sterile product, due to a lack of assurance of sterility. The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.

The affected product is Buckshot Injectable, Multi-Dose, Sterile, Room Temperature, manufactured by The Compounding Pharmacy of America in Knoxville, TN. The recall covers 426 ml of product distributed nationwide. Specific lots were distributed between November 2014 and May 2015, including lot 03232015@2 (distributed 6/21/2015), lot 05052015@8 (distributed 8/3/2015), and lot 04222015@7 (distributed 7/21/2015).

Consumers and healthcare providers should stop using the affected product and contact The Compounding Pharmacy of America for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Buckshot Injectable, Multi-Dose, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
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 (7)

All lots distributed between November 2014 and May 2015
03232015@2
6/21/2015
05052015@8
8/3/2015
04222015@7
7/21/2015

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

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Same hazard · sterility