The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0682-2016·Announced 2016-02-24

Abbott's Compounding Pharmacy Recalls Hydroxyprogesterone Due to Sterility Concerns

Abbott's Compounding Pharmacy is recalling all unexpired lots of hydroxyprogesterone in sesame oil because 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. According to the rubric, an FDA Class II recall involving a sterile product with sterility assurance concerns falls under the 'Severe' category (Score 4), as it implies a significant risk of harm.

Plain-English summary

Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of hydroxyprogesterone in sesame 250 mg/mL in 2 mL, 5 mL, 6 mL, and 8 mL unit sizes. The product was compounded by the firm located in Berkeley, CA.

The recall was initiated after an FDA inspection identified concerns regarding the lack of assurance of sterility for these sterile compounded products. The source text does not specify the number of units affected or the specific dates of distribution.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 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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