FDA Recall
CompletedHistorical recordClass II
Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown, NY 11756.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown, NY 11756.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.
by Ecometics, Inc.
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass III
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Subpotent: Out of Specification for Assay Test at the 3-month time point.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 22, 2024Historical recordClass III
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.
by Imprimis NJOF, LLC
- Reason
- Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 3, 2024Historical recordClass II
Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
by Parker Laboratories, Inc.
- Reason
- CGMP Deviations
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 3, 2024Historical recordClass II
Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004
by Parker Laboratories, Inc.
- Reason
- CGMP Deviations
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 3, 2024Historical recordClass II
Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
by Parker Laboratories, Inc.
- Reason
- CGMP Deviations
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 3, 2024Historical recordClass II
Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004
by Parker Laboratories, Inc.
- Reason
- CGMP Deviations
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 3, 2024Historical recordClass II
Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
by Parker Laboratories, Inc.
- Reason
- CGMP Deviations
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 26, 2024Historical recordClass II
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08
by Aurobindo Pharma USA Inc.
- Reason
- cGMP deviations: Batch was released prior to approval.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 26, 2024Historical recordClass II
Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-616-08
by Aurobindo Pharma USA Inc.
- Reason
- cGMP deviations: Batch was released prior to approval.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 14, 2024Historical recordClass I
Real Kosher Ice Cream, Inc.
- Product
- Soft Zero on the Go brand Lite Peanut Butter flavor; 8 fl oz…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- August 30, 2023
- Distribution
- CA, CO, CT, DC, DE, FL, IL, MA, MD, MI,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 14, 2024Historical recordClass I
Real Kosher Ice Cream, Inc.
- Product
- Soft Serve on the Go brand Sorbet Strawberry Mango Sorbet fl…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- August 30, 2023
- Distribution
- CA, CO, CT, DC, DE, FL, IL, MA, MD, MI,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 14, 2024Historical recordClass I
Real Kosher Ice Cream, Inc.
- Product
- Soft Serve on the Go brand Caramel Vanilla flavor; 8 fl oz;…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- August 30, 2023
- Distribution
- CA, CO, CT, DC, DE, FL, IL, MA, MD, MI,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 14, 2024Historical recordClass I
Real Kosher Ice Cream, Inc.
- Product
- Soft Serve on the Go brand Razzle n' Dazzle Peanut Butter fl…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- August 30, 2023
- Distribution
- CA, CO, CT, DC, DE, FL, IL, MA, MD, MI,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 14, 2024Historical recordClass I
Real Kosher Ice Cream, Inc.
- Product
- Soft Serve on the Go brand Vanilla Chocolate flavor; 8 fl oz…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- August 30, 2023
- Distribution
- CA, CO, CT, DC, DE, FL, IL, MA, MD, MI,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2024Historical recordClass II
Bickel's Snack Foods Inc
- Product
- Butter Flavored Popcorn Naturally & Artificially Flavored, 8…
- Reason
- Undeclared milk
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 1, 2024Historical recordClass II
Inmar Supply Chain Solutions, LLC
- Product
- Multiple FDA-regulated products. Pallets
- Reason
- Potential exposure to rodents and rodent activity in the warehouse.
- Published
- August 30, 2023
- 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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