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Class II: temporary or reversible health riskTerminated

JD & SN Inc., dba Moses Lake Professional Pharmacy Hydroxyprogesterone Caproate Oil Recall

HYDROXYPROGESTERONE CAPROATE OIL, injectable Solution, 250 mg/mL, syringe sizes: 4 mL

JD & SN Inc., dba Moses Lake Professional Pharmacy · Moses Lake, WA

Risk level
Class II
Reported by FDA
Nov 4, 2015
Recall ID
D-0100-2016
Check your lot numberHow we source this data

Summary

JD & SN Inc., dba Moses Lake Professional Pharmacy recalled Hydroxyprogesterone Caproate Oil starting Jul 24, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0100-2016 on Nov 4, 2015. Reason: Lack of Assurance of Sterility; all sterile human compounded drugs within expiry. Status: Terminated.

Why it was recalled

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

Product description

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 & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0100-2016
Classification
Class II
Status
Terminated
Recall initiated
Jul 24, 2015
FDA report date
Nov 4, 2015
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
Recall type
Voluntary: Firm initiated
Recalling firm
JD & SN Inc., dba Moses Lake Professional Pharmacy

Original FDA data

Every field from FDA enforcement report D-0100-2016, exactly as published.

Show all FDA fields
City
Moses Lake
State
WA
Status
Terminated
Country
United States
Event ID
71806
Address
1555 Pilgrim St
Code information
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
Postal code
98837-4623
Report date
Nov 4, 2015
Product type
Drugs
Recall number
D-0100-2016
Classification
Class II
Recalling firm
JD & SN Inc., dba Moses Lake Professional Pharmacy
Product 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
Termination date
Apr 13, 2016
Reason for recall
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Voluntary / mandated
Voluntary: Firm initiated
Product description
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 & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
Distribution pattern
Nationwide
Recall initiation date
Jul 24, 2015
Initial firm notification
Press Release
Center classification date
Oct 27, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0100-2016, published Nov 4, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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