The Recall Desk

FDA (Drugs) recall action 89986

McKesson Corporation dba McKesson Drug Company recalled 5 products on 2022-05-11

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2022-05-11
Critical
0
Units
144,013

Why these products were recalled

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

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.

States named across these recalls

1–5 of 5

  • ModerateFDA (Drugs)··2022-05-11

    Erythromycin Topical Gel Recalled Due to Manufacturing Quality Deviations

    McKesson Corporation is recalling Erythromycin Topical Gel USP 2% due to CGMP deviations. The manufacturer discontinued its stability study program, prompting a nationwide recall of all products within their expiration date.

    Product
    Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-053-68
    Category
    Distribution
    2 states
  • HighFDA (Drugs)··2022-05-11

    Betamethasone Dipropionate Ointment 0.05% recalled for manufacturing compliance failures

    McKesson Corporation is recalling 55,440 tubes of Betamethasone Dipropionate Ointment 0.05% (Augmented) nationwide due to manufacturing compliance deviations. The recall stems from the manufacturer's discontinuation of its stability study program.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 381
    Category
    Distribution
    2 states
  • HighFDA (Drugs)··2022-05-11

    Lidocaine Hydrochloride Topical Solution Recalled for Manufacturing Quality Deviations

    McKesson Corporation is recalling Lidocaine Hydrochloride Topical Solution due to manufacturing deviations related to discontinuation of the stability study program. Approximately 81,757 bottles distributed nationwide are affected.

    Product
    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64
    Category
    Distribution
    2 states
  • HighFDA (Drugs)··2022-05-11

    Halobetasol Propionate Ointment 0.05% Recalled Due to Manufacturing Practice Deviations

    McKesson Corporation is recalling Halobetasol Propionate Ointment 0.05% nationwide after the manufacturer discontinued its stability study program, creating CGMP deviations. Over 13,200 tubes distributed in the United States, Guam, and the Northern Mariana Islands are affected.

    Product
    Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67
    Category
    Distribution
    2 states
  • HighFDA (Drugs)··2022-05-11

    FDA Recalls Lidocaine Prilocaine Cream Due to Manufacturing Compliance Issue

    McKesson Corporation has recalled Lidocaine Prilocaine Cream 2.5%/2.5% because the manufacturer, Teligent Pharma, Inc., discontinued its stability study program, a deviation from manufacturing standards.

    Product
    Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66
    Category
    Distribution
    2 states