Why it was recalled
Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD37056_10, EXP: 5/10/2014; ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: W002567, EXP: 6/3/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD76686_4, EXP: 5/31/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 0053
Product description
CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582360
Lot numbers, UPCs & expiration codes
CHOLECALCIFEROL, Tablet, 400 units has the following codes Pedigree: AD37056_13, EXP: 5/10/2014; Pedigree: W002574, EXP: 6/3/2014; Pedigree: AD76686_7, EXP: 5/31/2014; Pedigree: AD60578_27, EXP: 5/29/2014; Pedigree: W003540, EXP: 6/21/2014; Pedigree: AD52993_25, EXP: 5/20/2014; Pedigree: W002715, EXP: 6/5/2014; Pedigree: AD30197_31, EXP: 5/9/2014; Pedigree: AD73592_8, EXP: 5/31/2014; Pedigree: W002642, EXP: 6/4/2014.
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-485-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 2, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 1,199 Tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidapak Services, LLC
Original FDA data
Every field from FDA enforcement report D-485-2014, 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
- CHOLECALCIFEROL, Tablet, 400 units has the following codes Pedigree: AD37056_13, EXP: 5/10/2014; Pedigree: W002574, EXP: 6/3/2014; Pedigree: AD76686_7, EXP: 5/31/2014; Pedigree: AD60578_27, EXP: 5/29/2014; Pedigree: W003540, EXP: 6/21/2014; Pedigree: AD52993_25, EXP: 5/20/2014; Pedigree: W002715, EXP: 6/5/2014; Pedigree: AD30197_31, EXP: 5/9/2014; Pedigree: AD73592_8, EXP: 5/31/2014; Pedigree: W002642, EXP: 6/4/2014.
- Postal code
- 98684-3501
- Report date
- Jan 22, 2014
- Product type
- Drugs
- Recall number
- D-485-2014
- Classification
- Class II
- Recalling firm
- Aidapak Services, LLC
- Product quantity
- 1,199 Tablets
- Termination date
- Feb 7, 2014
- Reason for recall
- Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD37056_10, EXP: 5/10/2014; ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: W002567, EXP: 6/3/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD76686_4, EXP: 5/31/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 0053
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582360
- 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