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Class III: unlikely to cause harmTerminated

Lupin Pharmaceuticals Famotidine for Oral Suspension Recall

Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for…

Lupin Pharmaceuticals Inc. · Baltimore, MD

Risk level
Class III
Reported by FDA
Sep 13, 2017
Recall ID
D-1127-2017
Check your lot numberHow we source this data

Summary

Lupin Pharmaceuticals recalled Famotidine for Oral Suspension starting May 2, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1127-2017 on Sep 13, 2017. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01

Lot numbers, UPCs & expiration codes

Lot #: G606950, Exp 07/18

Where it was sold

Nationwide in the USA

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-1127-2017
Classification
Class III
Status
Terminated
Recall initiated
May 2, 2017
FDA report date
Sep 13, 2017
Quantity
12,888 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Lupin Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-1127-2017, exactly as published.

Show all FDA fields
City
Baltimore
State
MD
Status
Terminated
Country
United States
Event ID
78032
Address
111 S Calvert St Fl 21ST
Code information
Lot #: G606950, Exp 07/18
Postal code
21202-6174
Report date
Sep 13, 2017
Product type
Drugs
Recall number
D-1127-2017
Classification
Class III
Recalling firm
Lupin Pharmaceuticals Inc.
Product quantity
12,888 bottles
Termination date
Mar 28, 2018
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01
Distribution pattern
Nationwide in the USA
Recall initiation date
May 2, 2017
Initial firm notification
E-Mail
Center classification date
Sep 1, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1127-2017, published Sep 13, 2017. 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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