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Class II: temporary or reversible health riskTerminated

Mckesson Packaging Services RANITIDINE Tablets Recall

RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal…

Mckesson Packaging Services · Concord, NC

Risk level
Class II
Reported by FDA
Mar 14, 2018
Recall ID
D-0914-2018
Check your lot numberHow we source this data

Summary

Mckesson Packaging Services recalled RANITIDINE Tablets starting Feb 26, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0914-2018 on Mar 14, 2018. Reason: Failed Stability Specifications. Status: Terminated.

Why it was recalled

Failed Stability Specifications

Product description

RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10

Lot numbers, UPCs & expiration codes

Lots: 0113064 Exp. 03/2018, 0114628 Exp. 08/2018, 0115189 Exp. 08/2018, 0115462 Exp. 09/2018

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-0914-2018
Classification
Class II
Status
Terminated
Recall initiated
Feb 26, 2018
FDA report date
Mar 14, 2018
Quantity
17,192 cartons (1,719,200 tablets)
Recall type
Voluntary: Firm initiated
Recalling firm
Mckesson Packaging Services

Original FDA data

Every field from FDA enforcement report D-0914-2018, exactly as published.

Show all FDA fields
City
Concord
State
NC
Status
Terminated
Country
United States
Event ID
79367
Address
7101 Weddington Rd Nw
Code information
Lots: 0113064 Exp. 03/2018, 0114628 Exp. 08/2018, 0115189 Exp. 08/2018, 0115462 Exp. 09/2018
Postal code
28027-3412
Report date
Mar 14, 2018
Product type
Drugs
Recall number
D-0914-2018
Classification
Class II
Recalling firm
Mckesson Packaging Services
Product quantity
17,192 cartons (1,719,200 tablets)
Termination date
Sep 15, 2020
Reason for recall
Failed Stability Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10
Distribution pattern
Nationwide
Recall initiation date
Feb 26, 2018
Initial firm notification
Letter
Center classification date
Jul 9, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0914-2018, published Mar 14, 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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