The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-892-2013·Announced 2013-08-21

American Health Packaging Recalls bupropion Hydrochloride Extended Release Tablets

American Health Packaging is recalling bupropion hydrochloride extended-release tablets due to failed stability specifications for color, dissolution, and related compounds.

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 by definition indicates that the product is not likely to cause adverse health consequences.

Plain-English summary

American Health Packaging is recalling 389 cartons of bupropion hydrochloride extended-release tablets, USP 100 mg. The affected product is identified by NDC 68084-470-01, Lot #114500, with an expiration date of 08/2013 and a repackaging date of 12/04/2011. The product was distributed nationwide.

The recall was initiated because the product failed stability specifications. Specifically, out-of-specification results were observed at the 9-month stability time point regarding color, dissolution, and related compounds.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
Manufacturer
American Health Packaging
Category
Drug — Prescription Medication
Hazard
Affected units
389

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 (3)

  • The following codes are affects by the recall: Lot #114500
  • Exipration Date 08/2013
  • repackaging date 12/04/2011.

Distribution

Distributed nationwide across the United States.

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