BuPROPion HCL Tablets Recalled for Moisture Content Failures
Mckesson Packaging Services is recalling BuPROPion HCL Tablets, 75 mg, due to out-of-specification moisture content.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The hazard is a moisture content failure, which is a quality control issue rather than a direct safety threat like contamination or mislabeling.
Plain-English summary
Mckesson Packaging Services is recalling 942 cartons of BuPROPion HCL Tablets, USP, 75 mg. The product is packaged as UD 100 tablets (10x10) and is marked Rx Only. The manufacturer is Sandoz Inc., and the NDC is 63739-706-10.
The recall was initiated because the product tested out-of-specification for moisture content. The affected lots are 0113148, 0113149, and 0113150 with an expiration date of 04/18; lot 0113636 with an expiration date of 06/18; and lot 0114513 with an expiration date of 10/18.
The product was distributed nationwide in the US. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- 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
- Manufacturer
- Mckesson Packaging Services
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 942
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot # 0113148
- 0113149
- 0113150
- Exp: 04/18
- 0113636
- Exp: 06/18
- 0114513
- Exp: 10/18
Distribution
Distributed nationwide across the United States.
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