Agency classClass IIOur severity:Severe FDA (Drugs)·D-1449-2015·Announced 2015-09-23

Bupivacaine Intrathecal Solution Recalled for Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Bupivacaine 15 mg/ml Intrathecal Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.

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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe. While no injuries are reported, the lack of sterility assurance in an intrathecal (spinal) injection product represents a significant risk of harm, aligning with the Severe criteria for high-risk products where injury has not yet been reported but the hazard is significant (Class II).

Plain-English summary

The Compounding Pharmacy of America is recalling Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free. The product is available in 22 mL quantities. The recall covers all lots distributed between November 2014 and May 2015, including lot 03092015@3 dated 6/7/2015. The distribution pattern is nationwide.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The specific concern cited is a lack of assurance of sterility for the intrathecal solution.

Healthcare providers and patients who have received this product should contact their healthcare provider for guidance. The source text does not specify a particular action for consumers beyond the general recall notice, nor does it report any illnesses or injuries associated with the product.

The recalled product

Product: Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Anesthetic
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
03092015@3
6/7/2015

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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Same hazard · sterility