Why it was recalled
Labeling: Label Mixup: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: AD21790_13, EXP: 5/1/2014; CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD46265_4, EXP: 5/15/2014; guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: W003678, EXP: 6/25/2014; guanFACIN
Product description
HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574025001.
Lot numbers, UPCs & expiration codes
HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg has the following codes: Pedigree: AD21790_19, EXP: 5/1/2014; Pedigree: AD46265_7, EXP: 5/15/2014; Pedigree: W003679, EXP: 6/25/2014; Pedigree: AD60272_16, EXP: 5/22/2014; Pedigree: AD30140_10, EXP: 5/7/2014; Pedigree: W003000, EXP: 6/11/2014; Pedigree: W003326, EXP: 6/19/2014.
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-959-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 2, 2013
- FDA report date
- Jan 29, 2014
- Quantity
- 909 Tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidapak Services, LLC
Original FDA data
Every field from FDA enforcement report D-959-2014, 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
- HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg has the following codes: Pedigree: AD21790_19, EXP: 5/1/2014; Pedigree: AD46265_7, EXP: 5/15/2014; Pedigree: W003679, EXP: 6/25/2014; Pedigree: AD60272_16, EXP: 5/22/2014; Pedigree: AD30140_10, EXP: 5/7/2014; Pedigree: W003000, EXP: 6/11/2014; Pedigree: W003326, EXP: 6/19/2014.
- Postal code
- 98684-3501
- Report date
- Jan 29, 2014
- Product type
- Drugs
- Recall number
- D-959-2014
- Classification
- Class II
- Recalling firm
- Aidapak Services, LLC
- Product quantity
- 909 Tablets
- Termination date
- Feb 7, 2014
- Reason for recall
- Labeling: Label Mixup: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: AD21790_13, EXP: 5/1/2014; CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD46265_4, EXP: 5/15/2014; guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: W003678, EXP: 6/25/2014; guanFACIN
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574025001.
- 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