FDAClass IINovember 4, 2015

Hydroxyprogesterone Caproate OIL recall: Sterility Concern

HYDROXYPROGESTERONE CAPROATE OIL, injectable Solution, 250 mg/mL, syringe sizes: 4 mL; 5 mL; 6 mL; 10 mL; 16 mL; 18 mL; 20 mL; and 22 mL, Rx only, JD…

Why was Hydroxyprogesterone Caproate OIL recalled?

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

t12182014@7, t12052014@12, t10312014@21, t10102014@21, t10072014@6, t09172014@30, t09152014@11, t08132014@13, t08112014@28, t07282014@28, t07282014@16, t07012015@7, t06302015@31, t06222015@17, t06112015@14, t06022015@17, t05182015@24, t05152015@19, t05072015@9, t04272015@19, t04232015@22, t04212015@16, t04162015@21, t04092015@2, t04022015@27, t03162015@16, t03052015@25, t03022015@13, t02272015@22, t02202015@23, t02172015@8, t02132015@19, 08202014@12, 05042015@11; t02062015@29, t03312015@5, t06052015@3, t06172015@47, t06292015@13, and t10232014@22, t07242014@6

Product
HYDROXYPROGESTERONE CAPROATE OIL, injectable Solution, 250 mg/mL, syringe sizes: 4 mL; 5 mL; 6 mL; 10 mL; 16 mL; 18 mL; 20 mL; and 22 mL, Rx only, JD…
Recalling firm
JD & SN Inc., dba Moses Lake Professional Pharmacy
Quantity
3 (4mL) syringes, 4 (5mL) syringes, 1 (6mL) syringe, 13 (10mL) syringes, 1 (16mL) syringe, 1 (18mL) syringe, 14 (20mL) syringes, 2 (22mL) syringes
Distribution
Nationwide
Recall date
November 4, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls