Agency classClass IIOur severity:Severe FDA (Drugs)·D-1544-2015·Announced 2015-09-23

FDA Recalls Hydromorphone and Bupivacaine Solution Due to Sterility Concerns

The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution because an FDA inspection found GMP violations that may affect sterility.

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, FDA Class II recalls with potential sterility issues in injectable products fall under the 'Severe' category (Score 4), as they involve significant risk to patient safety even without reported hospitalizations in the text.

Plain-English summary

The Compounding Pharmacy of America is recalling Hydromorphone 10 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free. The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.

The affected product is a 43 ml sterile solution. The recall covers all lots distributed nationwide between November 2014 and May 2015. The specific lot code identified is 02202015@5, with a date of 5/21/2015.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on return or replacement. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product: Hydromorphone 10 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Solution
Hazard: sterility
gmp-violation

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 (3)

All lots distributed between November 2014 and May 2015
02202015@5
5/21/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 382 recalled by The Compounding Pharmacy of America 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 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

See all →

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Hydromorphone Solution Recalled Due to Sterility Assurance Concerns
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Morphine and Bupivacaine Solution Recalled for Sterility Concerns
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Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
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Same hazard · sterility