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Class II: temporary or reversible health riskTerminated

Lupin Pharmaceuticals GaviLyte -C Recall

GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP w…

Lupin Pharmaceuticals Inc. · Baltimore, MD

Risk level
Class II
Reported by FDA
May 25, 2022
Recall ID
D-0875-2022
Check your lot numberHow we source this data

Summary

Lupin Pharmaceuticals recalled GaviLyte -C starting Apr 27, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0875-2022 on May 25, 2022. Reason: Failed Stability Specification. Status: Terminated.

Why it was recalled

Failed Stability Specification

Product description

GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19

Lot numbers, UPCs & expiration codes

Lot # S001132, exp. date July 2022 NDC # 43386-060-19

Where it was sold

Product was distributed nationwide, including Puerto Rico.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0875-2022
Classification
Class II
Status
Terminated
Recall initiated
Apr 27, 2022
FDA report date
May 25, 2022
Quantity
26,910 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Lupin Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0875-2022, exactly as published.

Show all FDA fields
City
Baltimore
State
MD
Status
Terminated
Country
United States
Event ID
90094
Address
Harborplace Tower
Address (line 2)
111 S Calvert St Fl 21st
Code information
Lot # S001132, exp. date July 2022 NDC # 43386-060-19
Postal code
21202-6174
Report date
May 25, 2022
Product type
Drugs
Recall number
D-0875-2022
Classification
Class II
Recalling firm
Lupin Pharmaceuticals Inc.
Product quantity
26,910 bottles
Termination date
Apr 13, 2023
Reason for recall
Failed Stability Specification
Voluntary / mandated
Voluntary: Firm initiated
Product description
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Distribution pattern
Product was distributed nationwide, including Puerto Rico.
Recall initiation date
Apr 27, 2022
Initial firm notification
Letter
Center classification date
May 16, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0875-2022, published May 25, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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