Agency classClass IIOur severity:Severe FDA (Drugs)·D-1678-2015·Announced 2015-09-23

FDA Recalls Compounded Intrathecal Pain Medication Due to Sterility Concerns

The Compounding Pharmacy of America is recalling a compounded intrathecal pain medication because FDA inspections 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 and involves a sterile intrathecal medication where sterility assurance is compromised, posing a risk of serious infection or injury.

Plain-English summary

The Compounding Pharmacy of America is recalling a specific compounded intrathecal solution containing hydromorphone, fentanyl, bupivacaine, clonidine, and baclofen. The recall is being conducted due to a lack of assurance of sterility. FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.

The affected product is a 66 ml sterile, preservative-free intrathecal solution. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes and dates identified in the recall include 03092015@17, 6/7/2015, 04032015@26, 7/2/2015, 5012015@15, and 7/30/2015.

Patients who have received this medication should contact their healthcare provider for guidance. 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.

The recalled product

Product: Hydromorphone 60 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 35 mg/ml + Clonidine 1,200 mcg/ml + Baclofen 90 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Sterile Preparation
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 (7)

All lots distributed between November 2014 and May 2015
03092015@17
6/7/2015
04032015@26
7/2/2015
5012015@15
7/30/2015

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