The Recall Desk

FDA (Drugs) recall action 87266

Teligent Pharma, Inc. recalled 3 products on 2021-05-05

The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2021-05-05
Critical
0
Units
184,200

Why these products were recalled

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

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.

1–3 of 3

  • LowFDA (Drugs)··2021-05-05

    Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity

    Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% due to failed impurity specifications. The product is distributed nationwide in 15-gram tubes.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2021-05-05

    Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity Failures

    Teligent Pharma is recalling 79,416 tubes of Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) because the product failed impurity specifications.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2021-05-05

    Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity Failure

    Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% because it failed impurity specifications for a known degradation product.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
    Category
    Distribution
    0 states