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Multiple Lots of Clindamycin Recalled

Pfizer Inc. is recalling Cleocin Phosphate (clindamycin) injection distributed by Pharmacia & Upjohn Co., a division of Pfizer, and clindamycin injection distributed by Alvogen Inc. after 24-month testing identified impurities in the products, according to the April 10, 2019, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes the following Cleocin Phosphate products distributed by Pharmacia & Upjohn in the United States and Guam:

  • Cleocin Phosphate injection, 300 mg/2 mL (150 mg/mL), 2 mL-vials (NDC 0009-6582-02) from lots T97469 (Exp. 7/19) and W28574 (Exp. 9/19);
  • Cleocin Phosphate injection, 600 mg/4 mL (150 mg/mL), 4 mL-vials (NDC 0009-3124-01) from lots T78191 (Exp. 4/19) and T97494 (Exp. 7/19); and  
  • Cleocin Phosphate injection, 900 mg/6 mL (150 mg/mL), 6-mL vials (NDC 0009-3447-01) from lot T78193 (Exp. 4/19).

Recalled clindamycin products distributed by Alvogen in the United States and Guam include the following: 

  • clindamycin injection, 300 mg/2 mL (150 mg/mL), 2-mL vials (NDC 47781-619-94) from lots T97472 (Exp. 7/19), T97473 (Exp. 4/19), W28573 (Exp. 9/19), and W31814 (Exp. 10/19); 
  • clindamycin injection, 600 mg/4 mL (150 mg/mL), 4-mL vials (NDC 47781-620-94) from lots T97496 (Exp. 4/19), T97497 (Exp. 7/19), W28564 (Exp. 9/19), and W31812 (Exp. 10/19); and
  • clindamycin injection, 900 mg/6 mL (150 mg/mL), 6-mL vials (NDC 47781-621-94) from lots T96398 (Exp. 7/19), T97492 (Exp. 4/19), W28567 (Exp. 9/19), and W31813 (Exp. 10/19). 

Pfizer voluntarily issued the recalls March 15, 2019. On March 29, 2019, the FDA designated them Class III, suggesting use of the affected products is not likely to cause adverse health consequences. 

Clindamycin injection a prescription antibiotic used to treat bacterial infections. 

Jolynn Tumolo

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