CLASS III Drug recall · Reported 10 Apr 2019 · FDA Enforcement Report
Clindamycin Injection, USP, 900 mg/ (150 mg/mL) vial recalled by Pfizer
Pfizer is recalling Clindamycin Injection, USP, 900 mg/ (150 mg/mL) vial, distributed nationwide in the US. The recall was initiated on 15 Mar 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1072-2019
- FDA event ID
- 82386
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Mar 2019
- FDA classified
- 29 Mar 2019
- Reported
- 10 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 15 Mar 2019 | Recall initiated by company | |
| 29 Mar 2019 | Classified by FDA | +14 days |
| 10 Apr 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide USA and Guam
Questions about this recall
Is Clindamycin Injection, USP, 900 mg/ (150 mg/mL) vial recalled?
Yes. Pfizer recalled Clindamycin Injection, USP, 900 mg/ (150 mg/mL) vial on 15 Mar 2019. The recall is Class III and its status is Terminated. Recall number D-1072-2019.
Why was it recalled?
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Which lots are affected?
Lot #: T96398, Exp.07/2019, T97492, Exp.04/2019, W28567, Exp. 09/2019, W31813, Exp.10/2019
Where was it sold?
Nationwide USA and Guam
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pfizer
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|---|---|---|---|---|---|
| Drug | CLASS II | Vial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalledSodium Bicarbonate | PFIZER | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ 1 mg/mL) recalled by PFIZER | PFIZER | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Bicillin L-A (penicllin G benzathine injectable suspension) per-vial recalledBicillin L-a | Pfizer | Particulate Matter | Nationwide |
Other Clindamycin recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack | RemedyRePack | Manufacturing (CGMP) Deviations | FL, PA, VA |
| Drug | CLASS II | Clindamycin Hydrochloride Capsules, USP, 300mg recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Hydrochloride Capsules, USP, 300mg recalledClindamycin Hydrochloride | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Hydrochloride Capsules, USP,150mg recalledClindamycin Hydrochloride | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Clindamycin Injection, USP, 300 mg/ (150 mg/mL) vials recalled by Pfizer | Pfizer | Potency & Assay | Nationwide |