Medications & Supplements/Prescription Drugs

Pfizer Inc.: Cleocin Phosphate and Clindamycin Injection Recalled for High Impurity Levels

Agency Publication Date: March 29, 2019

Summary

Pfizer Inc. has voluntarily recalled 19,286 units of Cleocin Phosphate (clindamycin injection) and generic Clindamycin Injection due to high levels of impurities detected during stability testing. The recalled products include various dosages and vial sizes (300 mg, 600 mg, and 900 mg) distributed under both the Cleocin Phosphate and Alvogen brands. These prescription injectable antibiotics were distributed nationwide throughout the United States and Guam between 2017 and 2019. Consumers who have these products should contact their healthcare provider or pharmacist immediately, as the medication has failed quality specifications for degradation at the 24-month mark.

Risk

The medication contains higher-than-allowed levels of impurities and degradation products that developed over time. Using medication that has exceeded its specification for impurities can lead to decreased drug effectiveness or unexpected side effects, although the risk is currently classified as low.

What You Should Do

Check your medication vials and outer cartons for the brand names Cleocin Phosphate or Clindamycin Injection and the following National Drug Codes (NDC): 0009-6582-02, 0009-3124-01, 0009-3447-01, 47781-619-94, 47781-620-94, or 47781-621-94.
Verify if your product matches the affected lot numbers and expiration dates: Cleocin 300mg (Lots T97469 Exp 7/2019, W28574 Exp 9/2019), Cleocin 600mg (Lots T78191 Exp 4/2019, T97494 Exp 7/2019), or Cleocin 900mg (Lot T78193 Exp 4/2019).
For Alvogen-labeled Clindamycin, check for: 300mg (Lots T97472 Exp 7/2019, T97473 Exp 4/2019, W28573 Exp 9/2019, W31814 Exp 10/2019), 600mg (Lots T97496 Exp 4/2019, T97497 Exp 7/2019, W28564 Exp 9/2019, W31812 Exp 10/2019), and 900mg (Lots T96398 Exp 7/2019, T97492 Exp 4/2019, W28567 Exp 9/2019, W31813 Exp 10/2019).
Contact your healthcare provider or pharmacist immediately for guidance if you possess any of these affected lots.
Return any unused product to the pharmacy or place of purchase for a refund and contact Pfizer Inc. at 235 E 42nd St, New York, NY for further instructions regarding the return process.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and product return for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial

Model:

NDC 0009-6582-02

Recall #: D-1067-2019

Lot Numbers:

T97469 (Exp. 7/2019)

W28574 (Exp. 09/2019)

Date Ranges: Exp. 7/2019, Exp. 09/2019

Product: Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial

Model:

NDC 0009-3124-01

Recall #: D-1068-2019

Lot Numbers:

T78191 (Exp. 04/2019)

T97494 (Exp. 07/2019)

Date Ranges: Exp. 04/2019, Exp. 07/2019

Product: Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial

Model:

NDC 0009-3447-01

Recall #: D-1069-2019

Lot Numbers:

T78193 (Exp. 04/2019)

Date Ranges: Exp. 04/2019

Product: Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials (Alvogen)

Model:

NDC 47781-619-94

Recall #: D-1070-2019

Lot Numbers:

T97472 (Exp 07/2019)

T97473 (Exp 04/2019)

W28573 (Exp 09/2019)

W31814 (Exp 10/2019)

Date Ranges: Exp 07/2019, Exp 04/2019, Exp 09/2019, Exp 10/2019

Product: Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials (Alvogen)

Model:

NDC 47781-620-94

Recall #: D-1071-2019

Lot Numbers:

T97496 (Exp 04/2019)

T97497 (Exp 07/2019)

W28564 (Exp 09/2019)

W31812 (Exp 10/2019)

Date Ranges: Exp 04/2019, Exp 07/2019, Exp 09/2019, Exp 10/2019

Product: Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial (Alvogen)

Model:

NDC 47781-621-94

Recall #: D-1072-2019

Lot Numbers:

T96398 (Exp 07/2019)

T97492 (Exp 04/2019)

W28567 (Exp 09/2019)

W31813 (Exp 10/2019)

Date Ranges: Exp 07/2019, Exp 04/2019, Exp 09/2019, Exp 10/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82386

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Pharmacies; Healthcare Facilities; Alvogen, Inc.; Pharmacia & Upjohn Co

Manufactured In: United States

Units Affected: 6 products (67 cartons (25 vials per carton); 820 cartons (25 vials per carton); 500 cartons (25 vials per carton); 701 cartons (25 vials per carton); 8,878 cartons (25 vials per carton); 8,320 cartons (25 vials per carton))

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medication vials and outer cartons for the brand names Cleocin Phosphate or Clindamycin Injection and the following National Drug Codes (NDC): 0009-6582-02, 0009-3124-01, 0009-3447-01, 47781-619-94, 47781-620-94, or 47781-621-94.

Verify if your product matches the affected lot numbers and expiration dates: Cleocin 300mg (Lots T97469 Exp 7/2019, W28574 Exp 9/2019), Cleocin 600mg (Lots T78191 Exp 4/2019, T97494 Exp 7/2019), or Cleocin 900mg (Lot T78193 Exp 4/2019).

For Alvogen-labeled Clindamycin, check for: 300mg (Lots T97472 Exp 7/2019, T97473 Exp 4/2019, W28573 Exp 9/2019, W31814 Exp 10/2019), 600mg (Lots T97496 Exp 4/2019, T97497 Exp 7/2019, W28564 Exp 9/2019, W31812 Exp 10/2019), and 900mg (Lots T96398 Exp 7/2019, T97492 Exp 4/2019, W28567 Exp 9/2019, W31813 Exp 10/2019).

Contact your healthcare provider or pharmacist immediately for guidance if you possess any of these affected lots.

Return any unused product to the pharmacy or place of purchase for a refund and contact Pfizer Inc. at 235 E 42nd St, New York, NY for further instructions regarding the return process.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial

Model:

NDC 0009-6582-02

Recall #: D-1067-2019

Lot Numbers:

T97469 (Exp. 7/2019)

W28574 (Exp. 09/2019)

Date Ranges: Exp. 7/2019, Exp. 09/2019

Product: Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial

Model:

NDC 0009-3124-01

Recall #: D-1068-2019

Lot Numbers:

T78191 (Exp. 04/2019)

T97494 (Exp. 07/2019)

Date Ranges: Exp. 04/2019, Exp. 07/2019

Product: Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial

Model:

NDC 0009-3447-01

Recall #: D-1069-2019

Lot Numbers:

T78193 (Exp. 04/2019)

Date Ranges: Exp. 04/2019

Product: Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials (Alvogen)

Model:

NDC 47781-619-94

Recall #: D-1070-2019

Lot Numbers:

T97472 (Exp 07/2019)

T97473 (Exp 04/2019)

W28573 (Exp 09/2019)

W31814 (Exp 10/2019)

Date Ranges: Exp 07/2019, Exp 04/2019, Exp 09/2019, Exp 10/2019

Product: Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials (Alvogen)

Model:

NDC 47781-620-94

Recall #: D-1071-2019

Lot Numbers:

T97496 (Exp 04/2019)

T97497 (Exp 07/2019)

W28564 (Exp 09/2019)

W31812 (Exp 10/2019)

Date Ranges: Exp 04/2019, Exp 07/2019, Exp 09/2019, Exp 10/2019

Product: Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial (Alvogen)

Model:

NDC 47781-621-94

Recall #: D-1072-2019

Lot Numbers:

T96398 (Exp 07/2019)

T97492 (Exp 04/2019)

W28567 (Exp 09/2019)

W31813 (Exp 10/2019)

Date Ranges: Exp 07/2019, Exp 04/2019, Exp 09/2019, Exp 10/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82386

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Pharmacies; Healthcare Facilities; Alvogen, Inc.; Pharmacia & Upjohn Co

Manufactured In: United States

Distributed To: Nationwide