FDA Recall
Terminated
Historical recordClass II
Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.
by Watson Pharmaceuticals
- Reason
- Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
by Warner Chilcott Company LLC
- Reason
- Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
- Published
- February 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
by Warner Chilcott Company LLC
- Reason
- Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
- Published
- February 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03
by Hillyard GMP
- Reason
- Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
- Published
- February 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
by Schering-Plough Products, LLC
- Reason
- Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
- Published
- February 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.
by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Reason
- Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
- Published
- February 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
- Published
- February 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01.
by Belmora LLC
- Reason
- Defective Container: Product lacks tamper evident breakaway band on cap.
- Published
- January 30, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit; Investigation Use only, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990.
by Genentech Inc
- Reason
- Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.
- Published
- January 30, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
by West-Ward Pharmaceutical Corp.
- Reason
- Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
- Published
- January 30, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
by West-Ward Pharmaceutical Corp.
- Reason
- Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
- Published
- January 30, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724.
by West-Ward Pharmaceutical Corp.
- Reason
- Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
- Published
- January 30, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.
by West-Ward Pharmaceutical Corp.
- Reason
- Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
- Published
- January 30, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
by James G. Cole, Inc.
- Reason
- Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
- Published
- January 23, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
by Teva Pharmaceuticals USA, Inc.
- Reason
- Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
- Published
- January 23, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.
by Upsher Smith Laboratories, Inc.
- Reason
- Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
- Published
- January 23, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
by Boehringer Ingelheim Roxane Inc
- Reason
- Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
- Published
- January 23, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040.
by L. Perrigo Co.
- Reason
- Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions
- Published
- January 23, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
by New England Compounding Center
- Reason
- Lack of Assurance of Sterility
- Published
- January 9, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
by New England Compounding Center
- Reason
- Lack of Assurance of Sterility
- Published
- January 9, 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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