Agency classClass IIOur severity:Severe FDA (Drugs)·D-1458-2015·Announced 2015-09-23

Cyanocobalamin Pellets Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Cyanocobalamin 10 mg Pellets because an FDA inspection found 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a sterile product, which carries a risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

The Compounding Pharmacy of America is recalling Cyanocobalamin 10 mg Pellets, Sterile, Room Temperature. The recall involves 32 pellets per unit. The product was distributed nationwide between November 2014 and May 2015. Specific lot codes include 03042015@33 with an expiration date of 8/31/2015, and 03312015@29 with an expiration date of 9/27/2015.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, meaning there is a lack of assurance that the pellets are sterile.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product: Cyanocobalamin 10 mg Pellet, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Sterile Product
Hazard: sterility
gmp-violation
Affected units: 32

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 (5)

All lots distributed between November 2014 and May 2015
03042015@33
8/31/2015
03312015@29
9/27/2015

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