FDA Recall
Terminated
Historical recordClass III
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11
by Pfizer Inc.
- Reason
- Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41; d) 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48); e) 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31); f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11
by Baxter Healthcare Corp.
- Reason
- Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
- Published
- July 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2
by Kareway Product Inc
- Reason
- Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
- Published
- July 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Published
- July 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Published
- July 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Published
- July 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Published
- July 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Published
- July 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Published
- July 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Published
- July 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Published
- July 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Published
- July 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
by Hill Dermaceuticals, Inc.
- Reason
- Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Published
- July 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC a) 0009-3124-03 and b) 0009-3447-03
by Pharmacia & Upjohn LLC
- Reason
- Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
- Published
- June 26, 2013
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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