The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0716-2016·Announced 2016-02-24

Abbott's Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded testosterone cypionate because an FDA inspection found concerns regarding the lack of 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 a sterile compounded product, which poses a risk of serious adverse health consequences such as infection, meeting the criteria for a Severe rating.

Plain-English summary

Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of compounded testosterone cypionate, 200 mg/mL, in 6 mL and 10 mL unit sizes. The recall was initiated after an FDA inspection identified concerns regarding the lack of assurance of sterility for these sterile compounded products.

The recalled products were distributed in California. The recall covers all lots of the affected product. 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, or where the probability of serious adverse health consequences is remote.

Consumers who have purchased or possess these products should stop using them and contact their healthcare provider or the recalling firm for further instructions on how to return or dispose of the medication.

The recalled product

Product
testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Manufacturer
Abbott's Compounding Pharmacy, Inc.
Category
Drug — Compounded Sterile Product
Hazard

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 1 state:

Part of a larger recall action

This product is one of 43 recalled by Abbott's Compounding Pharmacy, Inc. 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 43 products in this recall →

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