Agency classClass IIOur severity:Severe FDA (Drugs)·D-0223-2015·Announced 2014-11-12

FDA Recalls Compounded Testosterone Cypionate Injectable Due to Sterility Concerns

Oregon Compounding Centers is recalling compounded Testosterone Cypionate injectable vials due to quality control issues affecting sterility assurance.

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 lack of sterility assurance in an injectable product, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of Testosterone Cypionate (Grape Seed Oil/Compounded), 200mg/mL, injectable, 5 mL glass vials. The recall is being conducted due to concerns regarding quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection.

The affected product is distributed in Oregon and Washington. The specific lots subject to recall are Lot # 20140812@7 with a discard date of 2/8/2015, and Lot # 20140910@41 with a discard date of 3/9/2015. The total quantity involved is 175 mL.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. This recall is classified as FDA Class II.

The recalled product

Product: TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Compounded Injectable
Hazard: sterility
infection

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 (4)

Lot #: 20140812@7
discard date: 2/8/2015
Lot #: 20140910@41
discard date: 3/9/2015

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds 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 56 products in this recall →

Same manufacturer · Oregon Compounding Centers, Inc. dba Creative Compounds

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