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Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-56 Class III

Reason: Subpotent Drug

Fagron, Inc 20220304 Terminated
Distributed: Nationwide within the USA
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Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07 Class III

Reason: Subpotent Drug

Fagron, Inc 20220304 Terminated
Distributed: Nationwide within the USA
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Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05 Class III

Reason: Subpotent Drug

Fagron, Inc 20220304 Terminated
Distributed: Nationwide within the USA
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Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-04 Class III

Reason: Subpotent Drug

Fagron, Inc 20220304 Terminated
Distributed: Nationwide within the USA
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Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16 Class II

Reason: Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 20220401 Terminated
Distributed: Nationwide within USA
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Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16 Class II

Reason: Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 20220401 Terminated
Distributed: Nationwide within USA
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Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alcohol, OTC, Manufactured by: Lula Holdings LLC, 15532 St. Charles Avenue, New Orleans, LA, NDC 77348-001-02. Class II

Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.

Lula Holdings L.L.C. 20220405 Terminated
Distributed: LA
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buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86 Class III

Reason: Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

SUN PHARMACEUTICAL INDUSTRIES INC 20220429 Terminated
Distributed: Nationwide in the USA
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buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India Class III

Reason: Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

SUN PHARMACEUTICAL INDUSTRIES INC 20220429 Terminated
Distributed: Nationwide in the USA
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SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120. Class I

Reason: Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.

Fagron, Inc 20220304 Completed
Distributed: Nationwide USA and Puerto Rico, Canada, Columbia, France
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