November 17, 2021DrugsFDA
Vita Pharmacy, LLC dba Talon Compounding Pharmacy recalls ALPROSTADIL 30MCG/ML INJ 30MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San
Hazard: Lack of assurance of sterility
November 17, 2021DrugsFDA
Vita Pharmacy, LLC dba Talon Compounding Pharmacy recalls ALPROSTADIL 25MCG/ML 25MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Ant
Hazard: Lack of assurance of sterility
November 17, 2021DrugsFDA
Vita Pharmacy, LLC dba Talon Compounding Pharmacy recalls ALPROSTADIL 22MCG/ML 22MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Ant
Hazard: Lack of assurance of sterility
November 17, 2021DrugsFDA
Vita Pharmacy, LLC dba Talon Compounding Pharmacy recalls ALPROSTADIL 22.5MCG/ML 22.5MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San
Hazard: Lack of assurance of sterility
November 17, 2021DrugsFDA
Vita Pharmacy, LLC dba Talon Compounding Pharmacy recalls (WELL'S LIPO-LEAN)INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+ CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE in vials,
Hazard: Lack of assurance of sterility
November 17, 2021DrugsFDA
Vita Pharmacy, LLC dba Talon Compounding Pharmacy recalls Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharmacy, 2950
Hazard: Lack of assurance of sterility
November 17, 2021DrugsFDA
A-S Medication Solutions LLC. recalls Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60
Hazard: Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
November 17, 2021DrugsFDA
Precision Dose Inc. recalls Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a)
Hazard: cGMP Deviations: Product manufactured with contaminated raw ingredient.
November 17, 2021DrugsFDA
Precision Dose Inc. recalls Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count
Hazard: cGMP Deviations: Product manufactured with contaminated raw ingredient.
November 10, 2021DrugsFDA
MERCK SHARP & DOHME CORP recalls Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a
Hazard: Presence of Particulate Matter: Identified as Glass Particles
November 10, 2021DrugsFDA
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals recalls Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (
Hazard: Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
November 10, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-4
Hazard: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
November 10, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-4
Hazard: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
November 10, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Hazard: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
November 10, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
Hazard: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
November 10, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Hazard: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
November 10, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's La
Hazard: Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
November 10, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-9
Hazard: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
November 10, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-9
Hazard: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
November 10, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-9
Hazard: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
November 10, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-
Hazard: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
November 3, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775
Hazard: Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
November 3, 2021DrugsFDA
MACLEODS PHARMA USA, INC recalls Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Ma
Hazard: Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
November 3, 2021DrugsFDA
MACLEODS PHARMA USA, INC recalls Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Ma
Hazard: Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
November 3, 2021DrugsFDA
MACLEODS PHARMA USA, INC recalls Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33
Hazard: Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
November 3, 2021DrugsFDA
Ultra Seal Corporation recalls Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/
Hazard: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
November 3, 2021DrugsFDA
Ultra Seal Corporation recalls Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package
Hazard: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
November 3, 2021DrugsFDA
Ultra Seal Corporation recalls Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packag
Hazard: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
November 3, 2021DrugsFDA
Ultra Seal Corporation recalls North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets
Hazard: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
November 3, 2021DrugsFDA
Ultra Seal Corporation recalls AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in
Hazard: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.