Why it was recalled
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Product description
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86
Lot numbers, UPCs & expiration codes
Lot #: HAC2237A, exp. date 05/2023
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-0858-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 29, 2022
- FDA report date
- May 18, 2022
- Quantity
- 744 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0858-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90088
- Address
- 2 Independence Way
- Code information
- Lot #: HAC2237A, exp. date 05/2023
- Postal code
- 08540-6620
- Report date
- May 18, 2022
- Product type
- Drugs
- Recall number
- D-0858-2022
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 744 bottles
- Termination date
- Sep 25, 2023
- Reason for recall
- Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 29, 2022
- Initial firm notification
- Letter
- Center classification date
- May 10, 2022