Agency classClass IIOur severity:Severe FDA (Drugs)·D-1668-2015·Announced 2015-09-23

Calmme Injectable Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Calmme Injectable multi-dose vials because an FDA inspection 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 recall is classified as FDA Class II and involves a sterile injectable product with GMP violations impacting sterility, which aligns with the rubric for Severe severity (FDA Class II with potential for significant injury).

Plain-English summary

The Compounding Pharmacy of America is recalling Calmme Injectable, a sterile multi-dose vial product, due to a lack of assurance of sterility. The recall covers 296 ml of product distributed nationwide between November 2014 and May 2015.

An FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The agency has classified this recall as Class II.

Healthcare providers and patients who have received or possess this product should stop using it and contact the recalling firm or their healthcare provider for instructions on return or disposal.

The recalled product

Product: Calmme Injectable, Multi-Dose Vial, 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@1
6/21/2015
04222015@8
7/21/2015
05052015@7
8/3/2015

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