Agency classClass IIOur severity:Severe FDA (Drugs)·D-1673-2015·Announced 2015-09-23

Hydromorphone and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns

The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine Intrathecal Solution due to FDA inspection findings of GMP violations that may impact 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. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance issues in intrathecal products are classified as Severe (Score 4), as they carry a risk of serious injury or death if the product is not sterile.

Plain-English summary

The Compounding Pharmacy of America is recalling Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Preservative Free. The product is a 22 ml sterile solution distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, including lot 03232015@18 dated 6/21/2015.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, meaning there is a lack of assurance that the product is sterile.

Healthcare providers and patients who have received this product should contact their healthcare provider for guidance. The source text does not specify a specific consumer action other than the general context of a drug recall.

The recalled product

Product: Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Intrathecal 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
03232015@18
6/21/2015

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
FDA (Drugs) · 2015-09-23
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Morphine and Bupivacaine Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
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Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
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Same hazard · sterility