Why it was recalled
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Product description
Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA
Lot numbers, UPCs & expiration codes
a) Lot #: 148969, Exp 7/31/2022, b) Lot #: 148791, Exp 7/31/2022, c) Lot #: 148991, Exp 7/31/2022
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-0303-2021
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jan 27, 2021
- FDA report date
- Mar 24, 2021
- Quantity
- 35 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0303-2021, exactly as published.
Show all FDA fields
- City
- Burbank
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 87283
- Address
- 1919 N Victory Pl
- Code information
- a) Lot #: 148969, Exp 7/31/2022, b) Lot #: 148791, Exp 7/31/2022, c) Lot #: 148991, Exp 7/31/2022
- Postal code
- 91504-3425
- Report date
- Mar 24, 2021
- Product type
- Drugs
- Recall number
- D-0303-2021
- Classification
- Class I
- Recalling firm
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Product quantity
- 35 bottles
- Reason for recall
- Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 27, 2021
- Initial firm notification
- Center classification date
- Mar 16, 2021