The Recall Desk
ModerateFDA (Drugs)·D-1604-2014·Announced 2014-10-01

Hospira Recalls Buprenorphine Hydrochloride Injection Due to Impurity Failure

Hospira Inc. is recalling specific lots of Buprenorphine Hydrochloride Injection because the product failed impurity specifications during stability testing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or serious injuries are reported in the source text, fitting the criteria for minor labeling errors or low-risk contamination/precautionary recalls.

Plain-English summary

Hospira Inc. is recalling 373,180 Carpuject units of Buprenorphine Hydrochloride Injection, 0.3 mg base/mL. The affected product is distributed nationwide and includes Lot Numbers 35-730-LL and 35-745-LL, which expire on February 1, 2015. The recall was initiated because the product failed to meet impurity/degradation specifications, specifically showing out-of-specification results for the pseudobuprenorphine impurity at the 9-month stability time point.

This recall involves a prescription drug intended for intramuscular or intravenous use. 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, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should check their inventory and records for the specific lot numbers and expiration date listed above. If the product is found, it should be quarantined and not administered. Consumers should contact their healthcare provider for guidance on alternative treatments if they have been prescribed this specific medication.

The recalled product

Product
BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
Brand
BUPRENORPHINE HYDROCHLORIDE
Manufacturer
Hospira Inc.
Category
Drug — Injection
Hazard
Affected units
373,180

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)

  • Lot Number: 35-730-LL
  • 35-745-LL
  • Exp: 1 FEB 2015

Distribution

Distributed nationwide across the United States.

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