Oxycodone Hydrochloride Capsule Application # 200534 5 mg 100-count bottle Y
Oxycodone Hydrochloride Oral Solution Application # 200535 100 mg/5 mL 30 mL bottle Y
Oxycodone Hydrochloride Oral Solution, USP Application # 200535 5 mg/5 mL 500 mL bottle, 5 mL Unit Dose Cup, sold in package of 50 N
Potassium Chloride Oral Solution, USP Application # 206814 20 mEq/15 mL 473 mL bottle Y
Product Update:
New and improved formulation of Potassium Chloride Oral Solution, USP, 20 mEq/15 ml and 40 mEq/15 ml was approved by FDA in May 2019 and shipments began in July 2019. Due to changes in inactive ingredients a new formulation may appear lighter in color and lighter on taste. However, the new formulation meets the same specifications and has the same purity, potency, and safety standards as the old formulation.
The first lot of Potassium Chloride Oral Solution USP, 40 mEq/15 mL is Lot number 32401419A. The first lot of Potassium Chloride Oral Solution USP, 20 mEq/15 mL is lot number 32301719A. Later lots of the same product can be identified by examining the lot numbers, which begin with the same four digits, and the last two digits represent the year (19 being 2019, 20 being 2020). Thus, any lot code ending in 20, and any lot code ending in 19 that is higher than 32401419A or 32301719A were or will be manufactured with the new formulation.
PCS-31-083 rev. 3/2020
Potassium Chloride Oral Solution, USP Application # 206814 40 mEq/15 mL 473 mL bottle Y
Product Update:
New and improved formulation of Potassium Chloride Oral Solution, USP, 20 mEq/15 ml and 40 mEq/15 ml was approved by FDA in May 2019 and shipments began in July 2019. Due to changes in inactive ingredients a new formulation may appear lighter in color and lighter on taste. However, the new formulation meets the same specifications and has the same purity, potency, and safety standards as the old formulation.
The first lot of Potassium Chloride Oral Solution USP, 40 mEq/15 mL is Lot number 32401419A. The first lot of Potassium Chloride Oral Solution USP, 20 mEq/15 mL is lot number 32301719A. Later lots of the same product can be identified by examining the lot numbers, which begin with the same four digits, and the last two digits represent the year (19 being 2019, 20 being 2020). Thus, any lot code ending in 20, and any lot code ending in 19 that is higher than 32401419A or 32301719A were or will be manufactured with the new formulation.
PCS-31-083 rev. 3/2020
Potassium Chloride for Oral Solution, USP Application # 208019 20 mEq Unit Dose Pouch, for 20 mEq, sold in cases of 30 and 100 Y
Cocaine Hydrochloride Nasal Solution, USP Application # 209963 40 mg/mL 4 mL bottle Y
Product Update:
Beginning with lot number 36205720A, and for all subsequently-manufactured lots, the tamper-evident seal that covered the closure has been replaced with a press and turn tamper-evident closure to enhance the security of the packaged product. The new tamper-evident closure is designed to break once the bottle is opened leaving a plastic ring around the neck of the container. Also with this change, the inner liner has been changed to a cone liner.
The product can be identified by examining the lot number. Therefore, any lot code ending in 20 and that is “057” or higher were packaged with the new closure.
CHNS-31-085 rev 09/2020
Tivorbex (Indomethacin) Capsule (20mg) Application # N204768 20 mg 30-count bottle Y
Tivorbex (Indomethacin) Capsule (40mg) Application # N204768 40 mg 30-count bottle Y
Yosprala (aspirin and omeprazole) delayed-release tablet (81mg/40mg) Application # 205103 81 mg/40 mg sold in 30-count and 90-count bottles Y
See www.yospralahcp.com for more information Safety Data Sheet Approved Labeling
Yosprala (aspirin and omeprazole) delayed-release tablet (325mg/40mg) Application # 205103 325 mg/40 mg sold in 30-count and 90-count bottles Y
See www.yospralahcp.com for more information Safety Data Sheet Approved Labeling
Hycodan (Hydrocodone Bitartate and Homatropine Methylbromide) oral solution Application # 005213 5 mg Hydrocodone Bitartrate, USP and 1.5 mg Homatropine Methylbromide, USP per 5 mL 473 mL bottle Y
Hydrocodone Bitartate and Acetaminophen oral solution Application # 040894 7.5 mg Hydrocodone Bitartrate, USP and 325 mg Acetaminophen, USP per 15 mL 473 mL bottle N