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Class III: unlikely to cause harmTerminated

Mckesson Packaging Services BuPROPion HCL Tablets Recall

BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by:…

Mckesson Packaging Services · Concord, NC

Risk level
Class III
Reported by FDA
Jul 5, 2017
Recall ID
D-0928-2017
Check your lot numberHow we source this data

Summary

Mckesson Packaging Services recalled BuPROPion HCL Tablets starting May 30, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0928-2017 on Jul 5, 2017. Reason: Failed Moisture Limits: Product tested out-of-specification for moisture content. Status: Terminated.

Why it was recalled

Failed Moisture Limits: Product tested out-of-specification for moisture content.

Product description

BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10

Lot numbers, UPCs & expiration codes

Lot # 0113148, 0113149, 0113150, Exp: 04/18; 0113636, Exp: 06/18; 0114513, Exp: 10/18

Where it was sold

Nationwide in the US

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-0928-2017
Classification
Class III
Status
Terminated
Recall initiated
May 30, 2017
FDA report date
Jul 5, 2017
Quantity
942 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Mckesson Packaging Services

Original FDA data

Every field from FDA enforcement report D-0928-2017, exactly as published.

Show all FDA fields
City
Concord
State
NC
Status
Terminated
Country
United States
Event ID
77411
Address
7101 Weddington Rd NW
Code information
Lot # 0113148, 0113149, 0113150, Exp: 04/18; 0113636, Exp: 06/18; 0114513, Exp: 10/18
Postal code
28027-3412
Report date
Jul 5, 2017
Product type
Drugs
Recall number
D-0928-2017
Classification
Class III
Recalling firm
Mckesson Packaging Services
Product quantity
942 cartons
Termination date
Feb 6, 2020
Reason for recall
Failed Moisture Limits: Product tested out-of-specification for moisture content.
Voluntary / mandated
Voluntary: Firm initiated
Product description
BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10
Distribution pattern
Nationwide in the US
Recall initiation date
May 30, 2017
Initial firm notification
Letter
Center classification date
Jun 29, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0928-2017, published Jul 5, 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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