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Class III: unlikely to cause harmTerminated

Sun Pharmaceutical Industries Loperamide Hcl Tablets Recall

LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distribu…

Sun Pharmaceutical Industries, Inc. · Cranbury, NJ

Risk level
Class III
Reported by FDA
Jan 30, 2019
Recall ID
D-0391-2019
Check your lot numberHow we source this data

Summary

Sun Pharmaceutical Industries recalled Loperamide Hcl Tablets starting Dec 26, 2018. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0391-2019 on Jan 30, 2019. Reason: Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets. Status: Terminated.

Why it was recalled

Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.

Product description

LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256 Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24

Lot numbers, UPCs & expiration codes

Lot: 2979325, EXP 5/5021

Where it was sold

OH

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-0391-2019
Classification
Class III
Status
Terminated
Recall initiated
Dec 26, 2018
FDA report date
Jan 30, 2019
Quantity
5040 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Sun Pharmaceutical Industries, Inc.

Original FDA data

Every field from FDA enforcement report D-0391-2019, exactly as published.

Show all FDA fields
City
Cranbury
State
NJ
Status
Terminated
Country
United States
Event ID
81893
Address
270 Prospect Plains Rd
Code information
Lot: 2979325, EXP 5/5021
Postal code
08512-3605
Report date
Jan 30, 2019
Product type
Drugs
Recall number
D-0391-2019
Classification
Class III
Recalling firm
Sun Pharmaceutical Industries, Inc.
Product quantity
5040 cartons
Termination date
Apr 2, 2020
Reason for recall
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
Voluntary / mandated
Voluntary: Firm initiated
Product description
LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256 Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24
Distribution pattern
OH
Recall initiation date
Dec 26, 2018
Initial firm notification
Letter
Center classification date
Jan 23, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0391-2019, published Jan 30, 2019. 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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