The Recall Desk
ModerateFDA (Drugs)·D-1262-2014·Announced 2014-05-07

Piramal Recalls Sevoflurane Inhalation Anesthetic Due to pH Failure

Piramal Critical Care is recalling 12,600 bottles of Sevoflurane inhalation anesthetic because the product was too acidic, failing pH specifications.

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 due to a pH specification failure (product too acidic). Per the rubric, this falls under 'Minor labeling errors, low-risk contamination, voluntary precautionary recalls' as no specific injuries or illnesses are reported in the source text, and the defect is a chemical specification deviation rather than a high-risk pathogen or structural defect.

Plain-English summary

Piramal Critical Care, Inc. is recalling 12,600 bottles of Sevoflurane, USP (Inhalation Anesthetic), 250 mL Amber Bottle. The recall is due to the product failing pH specifications, specifically being too acidic. The affected product is a prescription-only medication manufactured by Piramal Critical Care, Inc., located in Bethlehem, PA.

The recall covers seven specific lots: S2611I28, S2511I14, S2531I16, S2721J21, S2871K03, S2881K03, and S2931K07. These lots have expiration dates ranging from September 2016 to November 2016. The product was distributed to wholesale distributors and retailers located nationwide.

Healthcare providers and consumers should stop using the affected lots of Sevoflurane and contact Piramal Critical Care, Inc. for further instructions or a return. 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
SEVOFLURANE (SEVOFLURANE)
Brand
SEVOFLURANE
Manufacturer
Piramal Critical Care, Inc.
Category
Drug — Inhalation Anesthetic
Hazard
Affected units
12,600

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)

  • Lot #: S2611I28 (exp 9/16)
  • S2511I14 (exp 9/16)
  • S2531I16 (exp 9/16)
  • S2721J21 (exp 10/16)
  • S2871K03 (exp 11/16)
  • S2881K03 (exp 11/16)
  • and S2931K07 (exp 11/16).

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · SEVOFLURANE

Same manufacturer · Piramal Critical Care, Inc.

See all →

Same hazard · ph failure

See all →