Agency classClass IIOur severity:Severe FDA (Drugs)·D-1546-2015·Announced 2015-09-23

FDA Recalls Hydromorphone Solution Due to Sterility Concerns

The Compounding Pharmacy of America is recalling Hydromorphone 15 mg/ml Solution because FDA inspections found 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a drug product, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant harm).

Plain-English summary

The Compounding Pharmacy of America is recalling Hydromorphone 15 mg/ml Solution, Sterile-Preservative Free. The product is distributed nationwide and consists of 22 ml total volumes. The recall covers all lots distributed between November 2014 and May 2015, including lot 03202015@67 dated June 18, 2015.

The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The lack of assurance of sterility poses a risk to patients using the medication.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on alternatives or returns.

The recalled product

Product: Hydromorphone 15 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
03202015@67
6/18/2015

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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FDA (Drugs) · 2015-09-23
Severe
Hydromorphone Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
Severe
Morphine and Bupivacaine Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
Severe
Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23

Same hazard · sterility