MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Family Dollar Stores
Class I - Dangerous
CGMP Deviations: product held outside appropriate storage temperature conditions.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
DULCOLAX 5 MG TABLET 25 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Family Dollar Stores
Class I - Dangerous
CGMP Deviations: product held outside appropriate storage temperature conditions.
FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Family Dollar Stores
Class I - Dangerous
CGMP Deviations: product held outside appropriate storage temperature conditions.
MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Family Dollar Stores
Class I - Dangerous
CGMP Deviations: product held outside appropriate storage temperature conditions.
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
Lupin Pharmaceuticals
Class I - Dangerous
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
Aire-Master of America
Class I - Dangerous
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
Nephron Sterile Compounding Center
Class I - Dangerous
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
Nephron Sterile Compounding Center
Class I - Dangerous
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class I - Dangerous
Defective Container: Product has incomplete induction seals.
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
Aire-Master of America
Class I - Dangerous
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
Aire-Master of America
Class I - Dangerous
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class I - Dangerous
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class I - Dangerous
cGMP Deviations: deviations leading to potential cross-contamination.
PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
Nephron Sterile Compounding Center
Class I - Dangerous
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class I - Dangerous
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Class I - Dangerous
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04
Nephron Sterile Compounding Center
Class I - Dangerous
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
Aire-Master of America
Class I - Dangerous
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class I - Dangerous
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.