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Class II: temporary or reversible health riskTerminated

Lupin Cefdinir powder for Oral Suspension Recall

Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68…

Lupin Pharmaceuticals Inc. · Baltimore, MD

Risk level
Class II
Reported by FDA
Apr 25, 2018
Recall ID
D-0684-2018
Check your lot numberHow we source this data

Summary

Lupin Pharmaceuticals recalled Lupin Cefdinir powder for Oral Suspension starting Mar 27, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0684-2018 on Apr 25, 2018. Reason: Superpotent Drug. Status: Terminated.

Why it was recalled

Superpotent Drug

Product description

Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202

Lot numbers, UPCs & expiration codes

Lot # F602241; Exp. 10/18 Lot # F602577; Exp. 11/18 Lot # F700036; Exp. 12/18

Where it was sold

Nationwide

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-0684-2018
Classification
Class II
Status
Terminated
Recall initiated
Mar 27, 2018
FDA report date
Apr 25, 2018
Quantity
40,824 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Lupin Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0684-2018, exactly as published.

Show all FDA fields
City
Baltimore
State
MD
Status
Terminated
Country
United States
Event ID
79612
Address
111 S Calvert St Fl 21ST
Code information
Lot # F602241; Exp. 10/18 Lot # F602577; Exp. 11/18 Lot # F700036; Exp. 12/18
Postal code
21202-6174
Report date
Apr 25, 2018
Product type
Drugs
Recall number
D-0684-2018
Classification
Class II
Recalling firm
Lupin Pharmaceuticals Inc.
Product quantity
40,824 bottles
Termination date
Apr 15, 2019
Reason for recall
Superpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
Distribution pattern
Nationwide
Recall initiation date
Mar 27, 2018
Initial firm notification
Letter
Center classification date
Apr 17, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0684-2018, published Apr 25, 2018. 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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