The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0781-2017·Announced 2017-05-24

Key Pharmacy Recalls SOD Phenylbutyrate Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling 91 vials of SOD Phenylbutyrate injections due to a lack of assurance of 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Key Pharmacy and Compounding Center is recalling 91 vials of SOD Phenylbutyrate SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ. The product is a prescription-only injection prepared in 30 mL glass single-dose vials.

The recall was initiated because the firm lacks assurance of the sterility of the compounded drugs. The affected lots were distributed nationwide in the U.S.A., as well as in Australia and Canada.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
91

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 (17)

  • Lot # t12-19-2016@76
  • Exp 4/27/2017
  • t11-28-2016@114
  • Exp 5/28/2017
  • t11-29-2016@102
  • Exp 5/29/2017
  • t12-06-2016@98
  • Exp 6/6/2017
  • t12-22-2016@118
  • Exp 6/21/2017
  • t12-22-2016@119
  • t02-06-2017@98
  • Exp 8/6/2017
  • t02-07-2017@60
  • Exp 8/7/2017
  • t02-21-2017@109
  • Exp 08/21/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Key Pharmacy and Compounding Center 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 79 products in this recall →

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