The Recall Desk

FDA (Drugs) recall action 63127

McKesson Packaging Services recalled 2 products on 2012-10-10

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-10-10
Critical
0
Units
861

Why these products were recalled

Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2012-10-10

    McKesson Recalls bupropion Hydrochloride Extended-Release Tablets Due to Dissolution Failure

    McKesson Packaging Services is recalling 187 cartons of bupropion Hydrochloride Extended-Release Tablets, 150 mg, because they failed USP dissolution test requirements.

    Product
    buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10…
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2012-10-10

    McKesson Recalls bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures

    McKesson Packaging Services is recalling bupropion hydrochloride extended-release tablets because they failed USP dissolution test requirements.

    Product
    buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10…
    Category
    Distribution
    0 states