FDA Recall
Terminated
Historical recordClass II
CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Landover, MD 20785, 1-877-846-9949, UPC 3 41520 00175 8.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30 mL) bottle, Distributed by: Scherer Labs International, LLC., 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02747 52531 1.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
by Amerigen Pharmaceuticals Inc.
- Reason
- Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901)
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories, Inc., Atlanta, GA 30339.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.
by Product Quest Manufacturing LLC
- Reason
- Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3.
by Product Quest Manufacturing LLC
- Reason
- Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.
by Product Quest Manufacturing LLC
- Reason
- Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.
by Product Quest Manufacturing LLC
- Reason
- Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.
by Product Quest Manufacturing LLC
- Reason
- Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341
by Product Quest Manufacturing LLC
- Reason
- Superpotent Drug: high out of specification assay results for the menthol ingredient.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1.
by Product Quest Manufacturing LLC
- Reason
- Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed by: Expedite Products, Inc., Tampa, FL 33619 USA, UPC 8 56569 00203 6.
by Product Quest Manufacturing LLC
- Reason
- Superpotent Drug: high out of specification assay results for the camphor ingredient.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7.
by Product Quest Manufacturing LLC
- Reason
- Failed Stability Specifications: separation of product and failure for actives.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7001-01, UPC 3 11917 18536 1.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Strength, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015,NDC 0363-7005-01, UPC 3 11917 18537 8.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- 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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