Why it was recalled
Labeling:Label Mixup; ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003899, EXP: 6/27/2014; MISOPROSTOL, Tablet, 100 mcg, NDC 43386016012, Pedigree: AD42611_7, EXP: 5/14/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003332, EXP: 6/18/2014; glyBURIDE, Tablet, 2.5 mg, NDC 0009383
Product description
ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175012837
Lot numbers, UPCs & expiration codes
ISOSORBIDE MONONITRATE ER Tablet, 30 mg has the following codes Pedigree: W003996, EXP: 7/1/2014; Pedigree: AD46297_1, EXP: 5/15/2014; Pedigree: W003350, EXP: 6/18/2014; Pedigree: AD21790_64, EXP: 5/1/2014; Pedigree: AD32757_37, EXP: 5/14/2014.
Where it was sold
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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-671-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 2, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 700 Tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidapak Services, LLC
Original FDA data
Every field from FDA enforcement report D-671-2014, exactly as published.
Show all FDA fields
- City
- Vancouver
- State
- WA
- Status
- Terminated
- Country
- United States
- Event ID
- 65707
- Address
- 14301 Se 1st St
- Code information
- ISOSORBIDE MONONITRATE ER Tablet, 30 mg has the following codes Pedigree: W003996, EXP: 7/1/2014; Pedigree: AD46297_1, EXP: 5/15/2014; Pedigree: W003350, EXP: 6/18/2014; Pedigree: AD21790_64, EXP: 5/1/2014; Pedigree: AD32757_37, EXP: 5/14/2014.
- Postal code
- 98684-3501
- Report date
- Jan 22, 2014
- Product type
- Drugs
- Recall number
- D-671-2014
- Classification
- Class II
- Recalling firm
- Aidapak Services, LLC
- Product quantity
- 700 Tablets
- Termination date
- Feb 7, 2014
- Reason for recall
- Labeling:Label Mixup; ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003899, EXP: 6/27/2014; MISOPROSTOL, Tablet, 100 mcg, NDC 43386016012, Pedigree: AD42611_7, EXP: 5/14/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003332, EXP: 6/18/2014; glyBURIDE, Tablet, 2.5 mg, NDC 0009383
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175012837
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Recall initiation date
- Jul 2, 2013
- Initial firm notification
- Telephone
- Center classification date
- Jan 16, 2014