Agency classClass IIOur severity:Severe FDA (Drugs)·D-286-2013·Announced 2013-05-01

Axium Healthcare Recalls 17 Alpha Hydroxyprogesterone Caproate Injectable Due to Sterility Concerns

Axium Healthcare Pharmacy is recalling 17 Alpha Hydroxyprogesterone Caproate Injectable vials due to lack of sterility assurance and quality control concerns.

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 identifies a lack of sterility assurance in an injectable drug, which poses a risk of serious infection. Per the rubric, FDA Class II recalls involving significant injury risks or structural defects in medical products are classified as Severe.

Plain-English summary

Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling 17 Alpha Hydroxyprogesterone Caproate Injectable. The product consists of 4 vials (5 mL each) and was distributed to Colorado, Georgia, Michigan, and Puerto Rico. The recall covers all lots of the product.

The recall was initiated due to a lack of assurance of sterility in all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA identified concerns associated with the pharmacy's quality control processes that compromise the sterility of the injectable medication.

Patients who have received this medication should contact their healthcare provider for guidance. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: 17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Manufacturer: Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Category: Drug — Injectable
Hazard: sterility-failure
infection-risk

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 (1)

ALL Lots

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 26 recalled by Axium Healthcare Pharmacy dba Balanced Solutions Compounding 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 26 products in this recall →

Same manufacturer · Axium Healthcare Pharmacy dba Balanced Solutions Compounding

See all →

Severe
FDA Recalls Triamcinolone Diacetate Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-05-01
Severe
FDA Recalls Methylcobalamin and Folic Acid Injectables Due to Sterility Concerns
FDA (Drugs) · 2013-05-01
Severe
Methylprednisolone Acetate Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2013-05-01
Severe
Progesterone Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2013-05-01
Severe
BiMix Standard Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2013-05-01

Same hazard · sterility failure