Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04. Class I

Reason: Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.

Nanomaterials Discovery Corporation 20230214 Ongoing
Distributed: Nationwide in the USA
DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1 Class III

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date

Akron Pharma, Inc. 20230217 Terminated
Distributed: Nationwide within the United States
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 Class II

Reason: CGMP DEVIATIONS

Ecometics, Inc. 20230224 Terminated
Distributed: Nationwide within the United States
Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155 Class II

Reason: CGMP DEVIATIONS

Ecometics, Inc. 20230224 Terminated
Distributed: Nationwide within the United States
Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 Class II

Reason: CGMP DEVIATIONS

Ecometics, Inc. 20230224 Terminated
Distributed: Nationwide within the United States
Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars Class II

Reason: CGMP DEVIATIONS

Ecometics, Inc. 20230224 Terminated
Distributed: Nationwide within the United States
Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 Class II

Reason: CGMP DEVIATIONS

Ecometics, Inc. 20230224 Terminated
Distributed: Nationwide within the United States
Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854 Class II

Reason: CGMP DEVIATIONS

Ecometics, Inc. 20230224 Terminated
Distributed: Nationwide within the United States
Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: The Larkspur Group Inc. South Norwalk, CT 06854 Class II

Reason: CGMP DEVIATIONS

Ecometics, Inc. 20230224 Terminated
Distributed: Nationwide within the United States
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94 Class II

Reason: CGMP DEVIATIONS

Denver Solutions, LLC DBA Leiters Health 20230221 Terminated
Distributed: Nationwide within the United States including VA or other Government facilities
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