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
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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
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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 →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
- Published
- June 26, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017.
by PFIZER INC
- Reason
- Failed Dissolution Specification
- Published
- June 26, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.
by Sagent Pharmaceuticals Inc
- Reason
- CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
- Published
- June 26, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
by Hi-Tech Pharmacal Co., Inc.
- Reason
- Subpotent; 24 month stability test station
- Published
- June 26, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
by Mission Pharmacal Co
- Reason
- Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
- Published
- June 26, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013
by Advance Pharmaceutical Inc
- Reason
- Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
- Published
- June 19, 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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