Class II · Moderate risk Ongoing
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827…
Reason cGMP deviations
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Class II · Moderate risk Ongoing
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC…
Reason cGMP deviations
Class II · Moderate risk Ongoing
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in…
Reason cGMP deviations
Class II · Moderate risk Ongoing
Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India…
Reason cGMP deviations
Class II · Moderate risk Ongoing
WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941…
Reason cGMP deviations
Class II · Moderate risk Ongoing
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street…
Reason cGMP deviations
Class II · Moderate risk Ongoing
Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in…
Reason cGMP deviations
Class II · Moderate risk Ongoing
Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY…
Reason cGMP deviations
Class II · Moderate risk Ongoing
Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made…
Reason cGMP deviations
Class II · Moderate risk Ongoing
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s…
Reason Failed Stability Specifications: Observed OOS results: eg results for colour index
Class I · High risk Ongoing
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc…
Reason Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of…
Class I · High risk Ongoing
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc…
Reason Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of…
Class II · Moderate risk Ongoing
Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC…
Reason Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Class II · Moderate risk Ongoing
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801…
Reason Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Class II · Moderate risk Ongoing
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ…
Reason Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
Class II · Moderate risk Ongoing
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ…
Reason Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
Class II · Moderate risk Ongoing
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ…
Reason Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
Class II · Moderate risk Ongoing
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ…
Reason Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
Class II · Moderate risk Ongoing
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ…
Reason Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
Class II · Moderate risk Ongoing
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ…
Reason Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
Class II · Moderate risk Ongoing
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ…
Reason Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
Class II · Moderate risk Ongoing
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reason Lack of Assurance of Sterility: Potential for flexible container leaks.
Class II · Moderate risk Ongoing
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen…
Reason Failed stability specifications: Out of specification for hardness test
Class II · Moderate risk Ongoing
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen…
Reason Failed stability specifications: Out of specification for hardness test
Class II · Moderate risk Ongoing
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad…
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate…