Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, NDC 73423-003-01; UPC Code: 8-40078-56493-2
Reason: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
D-0613-2024July 31, 2024Tampa, FL
GLOBAL WIDGET LLC
Class IIIOngoing
Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC Code: 8-40078-56612-7
Reason: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
D-0616-2024July 31, 2024Tampa, FL
Dr. Reddy's Laboratories, Inc.
Class IOngoing
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
Reason: Sub-potent Drug; powder discoloration associated with decreased potency
D-0486-2024May 15, 2024Princeton, NJ
Dr. Reddy's Laboratories, Inc.
Class IOngoing
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 435...
Reason: Sub-potent Drug; powder discoloration associated with decreased potency
D-0485-2024May 15, 2024Princeton, NJ
IntegraDose Compounding Services LLC
Class IIOngoing
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Off...
Reason: Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
D-0325-2024February 21, 2024Minneapolis, MN
Zyla Life Sciences US Inc.
Class IIIOngoing
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
Reason: Sub-potent Drug: Lower potency than labeled.
D-0094-2024November 15, 2023Lake Forest, IL
B. Braun Medical Inc
Class IITerminated
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,
Reason: Subpotent: Low anti-factor IIa Potency.
D-0579-2023May 24, 2023Irvine, CA
SCA Pharmaceuticals
Class IIITerminated
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44
Reason: Subpotent Drug: Out of specification results for low potency was obtained.
D-0555-2023May 3, 2023Windsor, CT
B. Braun Medical Inc
Class IITerminated
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.