Why it was recalled
Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potentially mislabeled as one of the following drugs: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD70585_7, EXP: 5/29/2014; THYROID, Tablet, 60 mg, NDC 00456045901, Pedigree: W002848, EXP: 6/7/2014; CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: W003744, EXP: 6/26/2014; amLOD
Product description
PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032122401.
Lot numbers, UPCs & expiration codes
PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units has the following codes: Pedigree: AD70585_10, EXP: 5/29/2014 Pedigree: W002850, EXP: 6/7/2014; Pedigree: W003856, EXP: 6/26/2014 Pedigree: AD65457_4, EXP: 5/24/2014; Pedigree: AD70655_1, EXP: 5/28/2014.
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-785-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 2, 2013
- FDA report date
- Jan 29, 2014
- Quantity
- 498 Capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidapak Services, LLC
Original FDA data
Every field from FDA enforcement report D-785-2014, 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
- PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units has the following codes: Pedigree: AD70585_10, EXP: 5/29/2014 Pedigree: W002850, EXP: 6/7/2014; Pedigree: W003856, EXP: 6/26/2014 Pedigree: AD65457_4, EXP: 5/24/2014; Pedigree: AD70655_1, EXP: 5/28/2014.
- Postal code
- 98684-3501
- Report date
- Jan 29, 2014
- Product type
- Drugs
- Recall number
- D-785-2014
- Classification
- Class II
- Recalling firm
- Aidapak Services, LLC
- Product quantity
- 498 Capsules
- Termination date
- Feb 7, 2014
- Reason for recall
- Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potentially mislabeled as one of the following drugs: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD70585_7, EXP: 5/29/2014; THYROID, Tablet, 60 mg, NDC 00456045901, Pedigree: W002848, EXP: 6/7/2014; CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: W003744, EXP: 6/26/2014; amLOD
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032122401.
- 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