Exact FDA event identifier

Event 82386

6 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 15, 2019
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Pfizer Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 6

Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02

D-1067-2019

Recall number: D-1067-2019
Initiated: March 15, 2019
Classification: Class III
Status: Terminated
Recalling firm: Pfizer Inc.
Quantity: 67 cartons (25 vials per carton)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: T97469, Exp. 7/2019, W28574, Exp.09/2019

Distribution pattern

Nationwide USA and Guam

drug · product 2 of 6

Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01

D-1068-2019

Recall number: D-1068-2019
Initiated: March 15, 2019
Classification: Class III
Status: Terminated
Recalling firm: Pfizer Inc.
Quantity: 820 cartons (25 vials per carton)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot#: T78191, Exp.04/2019, T97494, Exp.07/2019

Distribution pattern

Nationwide USA and Guam

drug · product 3 of 6

Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01

D-1069-2019

Recall number: D-1069-2019
Initiated: March 15, 2019
Classification: Class III
Status: Terminated
Recalling firm: Pfizer Inc.
Quantity: 500 cartons (25 vials per carton)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: T78193, Exp.04/2019

Distribution pattern

Nationwide USA and Guam

drug · product 4 of 6

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

D-1070-2019

Recall number: D-1070-2019
Initiated: March 15, 2019
Classification: Class III
Status: Terminated
Recalling firm: Pfizer Inc.
Quantity: 701 cartons (25 vials per carton)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot: T97472 (exp 07/2019), T97473 (exp 04/2019), W28573 (exp 09/2019), W31814 (exp 10/2019)

Distribution pattern

Nationwide USA and Guam

drug · product 5 of 6

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

D-1071-2019

Recall number: D-1071-2019
Initiated: March 15, 2019
Classification: Class III
Status: Terminated
Recalling firm: Pfizer Inc.
Quantity: 8,878 cartons (25 vials per carton)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: T97496, Exp.04/2019, T97497, Exp.07/2019, W28564(exp 09/2019), W31812, Exp. 10/2019.

Distribution pattern

Nationwide USA and Guam

drug · product 6 of 6

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

D-1072-2019

Recall number: D-1072-2019
Initiated: March 15, 2019
Classification: Class III
Status: Terminated
Recalling firm: Pfizer Inc.
Quantity: 8,320 cartons (25 vials per carton)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: T96398, Exp.07/2019, T97492, Exp.04/2019, W28567, Exp. 09/2019, W31813, Exp.10/2019

Distribution pattern

Nationwide USA and Guam