🍔 Food 💊 Drugs 🏥 Medical Devices
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09 Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

RemedyRepack Inc. 20220502 Terminated
Distributed: Product was distributed to FL, SC and VA
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Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09 Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

RemedyRepack Inc. 20220502 Terminated
Distributed: Product was distributed to FL, SC and VA
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Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00 Class II

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

RemedyRepack Inc. 20220504 Terminated
Distributed: Recalled product was distributed to Florida.
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Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 Class II

Reason: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions

Cardinal Health Inc. 20220405 Completed
Distributed: NM only
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Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80 Class II

Reason: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

Cardinal Health Inc. 20220405 Completed
Distributed: NM only
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Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59 Class I

Reason: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

Cardinal Health Inc. 20220405 Completed
Distributed: NM only
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Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2 Class III

Reason: Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

Apotex Corp. 20220503 Terminated
Distributed: Nationwide in the USA
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Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01 Class III

Reason: Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

American Health Packaging 20220503 Terminated
Distributed: Nationwide USA
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Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5 Class III

Reason: Subpotent drug: Low OOS for menthol content at the three month room temperature.

Bestco LLC 20220427 Terminated
Distributed: CA, ID, PA, OK
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Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16 Class III

Reason: Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content

Monarch PCM, LLC 20220414 Terminated
Distributed: TN only
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