Why it was recalled
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Product description
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01
Lot numbers, UPCs & expiration codes
Lot # 6727001 Exp 01/18
Where it was sold
MS
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-0572-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 9, 2015
- FDA report date
- Jan 27, 2016
- Quantity
- 9526
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
Original FDA data
Every field from FDA enforcement report D-0572-2016, exactly as published.
Show all FDA fields
- City
- Philadelphia
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 72382
- Address
- 1100 Orthodox St
- Code information
- Lot # 6727001 Exp 01/18
- Postal code
- 19124-3168
- Report date
- Jan 27, 2016
- Product type
- Drugs
- Recall number
- D-0572-2016
- Classification
- Class II
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
- Product quantity
- 9526
- Termination date
- Oct 13, 2016
- Reason for recall
- Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01
- Distribution pattern
- MS
- Recall initiation date
- Oct 9, 2015
- Initial firm notification
- Letter
- Center classification date
- Jan 19, 2016