Why it was recalled
Failed Dissolution Specifications
Product description
Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
Lot numbers, UPCs & expiration codes
Lot# 348913, Exp.01/18; Lot# 349552, Exp.03/18; Lot# 349681, Exp. 03/18; Lot# 349683, Exp. 03/18; Lot# 349685, Exp. 03/18; Lot# 349687, Exp. 03/18; Lot# 349689, Exp. 03/18; Lot# 350636, Exp.03/18
Where it was sold
Nationwide
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-0696-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 13, 2017
- FDA report date
- May 10, 2017
- Quantity
- 55,968 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn Inc
Original FDA data
Every field from FDA enforcement report D-0696-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 76831
- Address
- 1925 W Field Ct
- Code information
- Lot# 348913, Exp.01/18; Lot# 349552, Exp.03/18; Lot# 349681, Exp. 03/18; Lot# 349683, Exp. 03/18; Lot# 349685, Exp. 03/18; Lot# 349687, Exp. 03/18; Lot# 349689, Exp. 03/18; Lot# 350636, Exp.03/18
- Postal code
- 60045-4862
- Report date
- May 10, 2017
- Product type
- Drugs
- Recall number
- D-0696-2017
- Classification
- Class II
- Recalling firm
- Akorn Inc
- Product quantity
- 55,968 bottles
- Termination date
- Jul 9, 2019
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 13, 2017
- Initial firm notification
- Letter
- Center classification date
- May 4, 2017