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 →
FDA Recall
Terminated
Historical recordClass III
AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7.
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 Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.
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 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12900 3.
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 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6.
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 II
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India
by Aurobindo Pharma LTD
- Reason
- Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
- Published
- November 14, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066
by Coral Rock Man, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
- Published
- November 7, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, FL, Also, labeled as X-Rock 3 Day Pill For Erectile Refunction, Distributed by www. CoralXRock.Com, Florida Keys, Florida
by Coral Rock Man, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
- Published
- November 7, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792.
by XRock Industries, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
- Published
- November 7, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)
by Ben Venue Laboratories Inc
- Reason
- Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
- Published
- November 7, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403
by DermaCare, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
- Published
- November 7, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403
by DermaCare, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
- Published
- November 7, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.SA ***
by Mylan Pharmaceuticals Inc.
- Reason
- Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
- Published
- October 31, 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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