The Recall Desk
SevereFDA (Drugs)·D-0702-2016·Announced 2016-02-24

Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, due to FDA inspection findings regarding lack of sterility assurance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls are typically scored as 4 (Severe), especially when involving sterile products where sterility assurance is compromised, posing a risk of infection.

Plain-English summary

Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products. The recall includes the specific product papaverine phentolamine prostaglandin (25/1.5 mg/15 mcg/mL, 10 mL unit size). The recall was initiated after an FDA inspection identified concerns regarding the lack of sterility assurance for these products.

The recall covers all lots of the affected sterile compounded products. The distribution pattern is listed as California (CA). The source text does not specify the exact number of units recalled or the specific dates of distribution.

Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions. The source text does not provide specific contact information or a return address.

The recalled product

Product
papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Manufacturer
Abbott's Compounding Pharmacy, Inc.
Category
Drug — Compounded Sterile Products
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 →

Related recalls

Same manufacturer · Abbott's Compounding Pharmacy, Inc.

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Same hazard · sterility concern

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