Why it was recalled
Labeling: Label Mixup: guanFACINE HCl, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: W002727, EXP: 6/6/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD39588_7, EXP: 5/13/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003873, EXP: 6/2
Product description
guanFACINE HCl, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591044401.
Lot numbers, UPCs & expiration codes
guanFACINE HCl, Tablet, 1 mg has the following codes: Pedigree: W002728, EXP: 4/30/2014; Pedigree: AD39611_1, EXP: 4/30/2014; Pedigree: W003791, EXP: 6/27/2014; Pedigree: AD73525_13, EXP: 4/30/2014.
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-965-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 2, 2013
- FDA report date
- Jan 29, 2014
- Quantity
- 500 Tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidapak Services, LLC
Original FDA data
Every field from FDA enforcement report D-965-2014, exactly as published.
Show all FDA fields
- City
- Vancouver
- State
- WA
- Status
- Terminated
- Country
- United States
- Event ID
- 65690
- Address
- 14301 Se 1st St
- Code information
- guanFACINE HCl, Tablet, 1 mg has the following codes: Pedigree: W002728, EXP: 4/30/2014; Pedigree: AD39611_1, EXP: 4/30/2014; Pedigree: W003791, EXP: 6/27/2014; Pedigree: AD73525_13, EXP: 4/30/2014.
- Postal code
- 98684-3501
- Report date
- Jan 29, 2014
- Product type
- Drugs
- Recall number
- D-965-2014
- Classification
- Class II
- Recalling firm
- Aidapak Services, LLC
- Product quantity
- 500 Tablets
- Termination date
- Feb 7, 2014
- Reason for recall
- Labeling: Label Mixup: guanFACINE HCl, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: W002727, EXP: 6/6/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD39588_7, EXP: 5/13/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003873, EXP: 6/2
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- guanFACINE HCl, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591044401.
- 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 20, 2014