FDA Recall
Terminated
Historical recordClass II
Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12
by Procter & Gamble Co
- Reason
- Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.
- Published
- December 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06
by GlaxoSmithKline, LLC.
- Reason
- Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
- Published
- December 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
by Boehringer Ingelheim Roxane Inc
- Reason
- Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
- Published
- December 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.
by GlaxoSmithKline, LLC.
- Reason
- Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
- Published
- December 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.
by GlaxoSmithKline, LLC.
- Reason
- Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
- Published
- December 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
by Samantha Lynn, Inc
- Reason
- Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.
- Published
- December 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7.
by Church & Dwight Inc
- Reason
- CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
- Published
- November 28, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90
by Ranbaxy Inc.
- Reason
- Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
- Published
- November 28, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
- Published
- November 28, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
by Watson Laboratories Inc
- Reason
- Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
- Published
- November 28, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Reason
- Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
- Published
- November 28, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured for S.P. Richards Co., 6300 Highlands Pkwy., Smyma, GA 30082, UPC 0 35255 10477 7; b) Pro Chem Lemon Aid, Hand Sanitizing Wipes, 85-count premoistened wipes per bucket, 6 buckets per case, An exclusive product of: Pro Chem, Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004; c) Scrubs, Lemon Hand Sanitizer Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured in the U.S.A. by ITW Dymon, 805 E. Old 56 Highway, Olathe, KS 66061, UPC 7 64769 92991 9.
by ITW Dymon
- Reason
- CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
- Published
- November 21, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
by Ameridose LLC
- Reason
- GMP deficiencies
- Published
- November 21, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
by Ameridose LLC
- Reason
- Lack of assurance of sterility
- Published
- November 21, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
by New England Compounding Center
- Reason
- GMP Deviations
- Published
- November 21, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
by New England Compounding Center
- Reason
- Lack of Assurance of Sterility
- Published
- November 21, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2.
by Valeant Pharmaceuticals
- Reason
- Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
- Published
- November 14, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9.
by Valeant Pharmaceuticals
- Reason
- Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
- Published
- November 14, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6.
by Valeant Pharmaceuticals
- Reason
- Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
- Published
- November 14, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.
by Valeant Pharmaceuticals
- Reason
- Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
- Published
- November 14, 2012
- 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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