Guidance: Easy read guide to the MMRV vaccination
Easy read information on the MMRV vaccination which protects against measles, mumps, rubella and varicella.
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Easy read information on the MMRV vaccination which protects against measles, mumps, rubella and varicella.
Original new drug approval. solution, oral. Sponsor: Cmp Dev Llc
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 6076306 cartons
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 2910148 cartons
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Presence of Particulate Matter: Hair was found in products — Fresenius Kabi USA, LLC · Class II · Ongoing · 92,600 vials
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 65219 cartons
Presence of Particulate Matter: Hair was found in products — Fresenius Kabi USA, LLC · Class II · Ongoing · 93,250 vials
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 97201 cartons
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Presence of Particulate Matter: Hair was found in products — Fresenius Kabi USA, LLC · Class II · Ongoing · 181,225 vials
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 499,673 cartons
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan — Asclemed USA Inc. · Class III · Ongoing · 18 kits
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications — Ascend Laboratories, LLC · Class II · Ongoing · 6,192 bottles
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Due to an out-of-specification result for an unidentified impurity detected during routine stability testing. — Precision Dose Inc. · Not Yet Classified · Ongoing · N/A
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 1,278,457 cartons
Presence of Particulate Matter: Hair was found in products — Fresenius Kabi USA, LLC · Class II · Ongoing · 37,250 vials