🍔 Food 💊 Drugs 🏥 Medical Devices
Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer With Broad Spectrum SPF 30 Sunscreen, Net Wt. 1.7 FL. OZ. (50 mL) Class II

Reason: cGMP deviations: product stored outside of labeled temperature requirements.

Family Dollar Stores, Llc. 20220517 Ongoing
Distributed: USA Nationwide
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Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08 Class II

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

Strides Pharma Inc. 20220518 Terminated
Distributed: Nationwide
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Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08 Class II

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

Strides Pharma Inc. 20220518 Terminated
Distributed: Nationwide
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Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08 Class II

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

Strides Pharma Inc. 20220518 Terminated
Distributed: Nationwide
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Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90 Class II

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

Direct Rx 20220505 Terminated
Distributed: AL, GA, FL, LA
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Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800 9 Class II

Reason: Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.

Vi-Jon, LLC 20220505 Terminated
Distributed: Nationwide in the USA
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Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05 Class II

Reason: Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC 20220518 Terminated
Distributed: Nationwide in the USA
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Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05 Class II

Reason: Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC 20220518 Terminated
Distributed: Nationwide in the USA
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Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10 Class II

Reason: Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC 20220518 Terminated
Distributed: Nationwide in the USA
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Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10 Class II

Reason: Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC 20220518 Terminated
Distributed: Nationwide in the USA
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