Why it was recalled
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
Product description
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05
Lot numbers, UPCs & expiration codes
Lot 6848501, EXP 04/2020
Where it was sold
Nationwide in the USA
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-0802-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 19, 2018
- FDA report date
- May 23, 2018
- Quantity
- 1,908 500-count bottles
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0802-2018, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79909
- Address
- 270 Prospect Plains Rd
- Code information
- Lot 6848501, EXP 04/2020
- Postal code
- 08512-3605
- Report date
- May 23, 2018
- Product type
- Drugs
- Recall number
- D-0802-2018
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 1,908 500-count bottles
- Termination date
- Feb 28, 2019
- Reason for recall
- Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
- Product description
- Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 19, 2018
- Initial firm notification
- Letter
- Center classification date
- May 11, 2018