The Recall Desk

FDA (Drugs) recall action 82386

Pfizer Inc. recalled 6 products on 2019-04-10

The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2019-04-10
Critical
0
Units

Why these products were recalled

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

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

States named across these recalls

1–6 of 6

  • ModerateFDA (Drugs)··2019-04-10

    Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures

    Pfizer is recalling specific lots of Clindamycin Injection due to high out-of-specification impurity results at the 24-month time point.

    Product
    Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2019-04-10

    Pfizer Recalls Clindamycin Injection Due to Impurity Specification Failures

    Pfizer is recalling specific lots of Clindamycin Injection because high out-of-specification impurities were found at the 24-month time point.

    Product
    Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2019-04-10

    Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures

    Pfizer is recalling specific lots of Clindamycin Injection because high levels of impurities were found at the 24-month time point.

    Product
    Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
    Category
    Distribution
    1 state