Pharmacia & Upjohn Company LLC
NDC labeler code: 0009
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- MethylprednisoloneSolu-Medrol, Medrol · 14 products
- ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 12 products
- HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 8 products
- Methylprednisolone acetateDepo-Medrol · 6 products
- Medroxyprogesterone acetateProvera, Depo-Provera, Depo-Subq Provera · 6 products
- AlprostadilEdex, Prostin Vr Pediatric, Caverject Impulse · 6 products
- LinezolidZyvox · 4 products
- Testosterone cypionateDepo-Testosterone, Azmiro · 4 products
- Irinotecan hydrochlorideCamptosar, Onivyde · 3 products
- AlprazolamXanax, Xanax XR · 3 products
- Ibutilide fumarateCorvert · 2 products
- LincomycinLincocin · 2 products
- Colestipol hydrochlorideColestid · 2 products
- Epirubicin hydrochlorideEllence · 2 products
- ExemestaneAromasin · 1 product
- Arginine hydrochlorideR-Gene · 1 product
- Clindamycin palmitate hydrochlorideClindamycin Palmitate Hydrochloride (Pediatric), Cleocin Pediatric · 1 product
- Carboprost tromethamineHemabate · 1 product
- DinoprostoneCervidil, Prepidil · 1 product
- Estradiol cypionateDepo-Estradiol · 1 product
- NicotineNicotrol · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2022
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April 13, 2022 · Class II · Terminated · D-1096-2022 · Methylprednisolone acetate
cGMP deviations: Temperature abuse
Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL, 1 mL single-dose vial, Rx only, MFG: Pfizer, NDC 0009-3073-03
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April 13, 2022 · Class II · Terminated · D-1097-2022 · Methylprednisolone acetate
cGMP deviations: Temperature abuse
Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in a) 1 mL single-dose vial (NDC# 0009-3475-01), b) 25-count box (NDC 0009-3475-03), Rx only, MFG: Pfizer
2019
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March 15, 2019 · Class III · Terminated · D-1067-2019 · Clindamycin
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
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
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March 15, 2019 · Class III · Terminated · D-1069-2019 · Clindamycin
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
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
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March 15, 2019 · Class III · Terminated · D-1068-2019 · Clindamycin
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
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
2015
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September 24, 2015 · Class II · Terminated · D-0161-2016 · Alprazolam
Subpotent Drug
Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division of Pfizer Inc, NY, NY 10017, NDC 0009-0029-01
2014
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July 30, 2014 · Class III · Terminated · D-1537-2014 · Methylprednisolone acetate
Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0
Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017 NDC 0009-3073-03 DEPO-MEDROL m
2013
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June 4, 2013 · Class II · Terminated · D-609-2013 · Clindamycin
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container,
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026