🍔 Food 💊 Drugs 🏥 Medical Devices
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455 Class I

Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

Pyramids Wholesale Inc. 20240319 Ongoing
Distributed: Nationwide in the USA
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S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03 Class II

Reason: Failed Stability Specifications

Specialty Process Labs LLC 20240301 Completed
Distributed: U.S. Nationwide.
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S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01. Class II

Reason: Failed Stability Specifications

Specialty Process Labs LLC 20240301 Completed
Distributed: U.S. Nationwide.
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Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01 Class II

Reason: CGMP Deviations

Eli Lilly & Company 20240312 Completed
Distributed: Nationwide USA
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Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12. Class I

Reason: Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.

AvKARE 20240328 Terminated
Distributed: US Nationwide.
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Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10 Class III

Reason: Failed Impurities/Degradation Specifications

Novitium Pharma LLC 20240325 Terminated
Distributed: U.S. Nationwide
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Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 Class I

Reason: Superpotent Drug: Due to overfilling of drug powder

Amneal Pharmaceuticals of New York, LLC 20240321 Terminated
Distributed: Nationwide in the USA.
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NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03 Class III

Reason: Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.

Esperion 20240327 Completed
Distributed: Nationwide in the USA
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Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10 Class I

Reason: Presence of Particulate Matter

Eugia US LLC 20240215 Ongoing
Distributed: Nationwide in the USA
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Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15 Class II

Reason: Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

Teva Pharmaceuticals USA, Inc 20240328 Ongoing
Distributed: Nationwide in the USA
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