The Recall Desk
SevereFDA (Drugs)·D-0703-2016·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 source text explicitly states the agency classification is Class II. According to the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4. Since this is a Class II recall involving a sterile product with sterility assurance concerns, it falls under the 'Severe' category (Score 4) as it involves a significant risk of harm (infection) even without specific hospitalization reports in the text.

Plain-English summary

Abbott's Compounding Pharmacy, Inc. is recalling all unexpired lots of sterile compounded products, specifically papaverine phentolamine prostaglandin (25/1 mg/30 mcg/mL, 10 mL unit size). The recall is being conducted after an FDA inspection identified concerns regarding the lack of assurance of sterility for these products.

The affected products were distributed in California. The recall covers all lots of the specified sterile compounded products. 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.

Consumers and healthcare providers should stop using the affected products and contact Abbott's Compounding Pharmacy, Inc. for further instructions or a refund. Patients should consult their healthcare provider regarding alternative treatments if necessary.

The recalled product

Product
papaverine phentolamine prostaglandin; 25/1 mg/30 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 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 →

Related recalls

Same manufacturer · Abbott's Compounding Pharmacy, Inc.

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Same hazard · sterility concern

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