FDA Recall
Terminated
Historical recordClass III
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
by PACK Pharmaceuticals, LLC
- Reason
- Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
by PACK Pharmaceuticals, LLC
- Reason
- Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
by PACK Pharmaceuticals, LLC
- Reason
- Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
by PACK Pharmaceuticals, LLC
- Reason
- Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.
by Apothecure, Inc
- Reason
- Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05.
by Forest Pharmaceuticals Inc
- Reason
- Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29.
by Forest Pharmaceuticals Inc
- Reason
- Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33
by Forest Pharmaceuticals Inc
- Reason
- Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56
by Teva Pharmaceuticals USA, Inc.
- Reason
- Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)
by Actavis Inc
- Reason
- Failed Tablet/Capsule Specifications: Broken tablets
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2
by Greenstone Llc
- Reason
- Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66
by Pfizer Inc.
- Reason
- Failed Dissolution Specification; 8 hr stability timepoint
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02
by Baxter Healthcare Corp.
- Reason
- Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.
by Insight Instruments, Inc.
- Reason
- Marketed without an Approved NDA/ANDA.
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
- Published
- February 12, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244
by NuVision Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
- Published
- February 5, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
by NuVision Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
- Published
- February 5, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com
by IQ Formulations, LLC
- Reason
- Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug
- Published
- February 5, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.
by Alexion Pharmaceuticals, Inc.
- Reason
- Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
- Published
- February 5, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Aqueous solution. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic. Sold under the following brands: a) Good Neighbor Pharmacy NDC 24385-593-46 , b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value UPC 4098602556; e) Rite Aid Pharmacy UPC 011822576871; f) TopCare UPC 3680033436; g) Vida Mia UPC 847717060718; h) Humco 2 fl. oz NDC 0395-1637-92 i) Humco 3 fl. oz. NCD 0395-1637-93 ; 2 fl OZ (59 mL) and 3 FL OZ (90 mL) bottles, HUMCO, Texarkana, TX 75501.
by Humco Holding Group, Inc
- Reason
- Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
- Published
- February 5, 2014
- 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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