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 →
FDA Recall
Terminated
Historical recordClass I
MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL
by OLAAX International
- Reason
- Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
- Published
- June 19, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
by Actavis
- Reason
- Failed Impurities/Degradation Specifications
- 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.
Read the full medical disclaimer.