Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01
Lot numbers, UPCs & expiration codes
Lot #: 15429401, Exp. Date 08/2023
Where it was sold
Nationwide within the United States
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-0061-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 10, 2022
- FDA report date
- Nov 23, 2022
- Quantity
- 218 bottles/100 capsules per bottle
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Formulations Private Limited
Original FDA data
Every field from FDA enforcement report D-0061-2023, exactly as published.
Show all FDA fields
- City
- Chennai
- Status
- Terminated
- Country
- India
- Event ID
- 91110
- Address
- 9/215 Pudupakkam-Vandalur Main Road
- Address (line 2)
- Pudupakkam, Kelambakkam
- Code information
- Lot #: 15429401, Exp. Date 08/2023
- Report date
- Nov 23, 2022
- Product type
- Drugs
- Recall number
- D-0061-2023
- Classification
- Class II
- Recalling firm
- Par Formulations Private Limited
- Product quantity
- 218 bottles/100 capsules per bottle
- Termination date
- Aug 18, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Nov 15, 2022