Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown…
Aurobindo Pharma USA Inc · shortfill; reports of empty capsules.
- Status
- Ongoing
- City
- East Windsor
- State
- NJ
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99492
- Recalling firm
- Aurobindo Pharma USA Inc
- Address 1
- 279 Princeton Hightstown Rd
- Postal code
- 08520-1401
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide.
- Recall number
- D-0733-2026
- Product quantity
- 6,408 bottles distributed to market
- Reason for recall
- shortfill; reports of empty capsules.
- Recall initiation date
- 20260723
- Center classification date
- 20260804
- Report date
- 20260812
- Code info
- Batch # DMC125018A, Exp Date: 07/2027.
- Product description
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
- Harmonized identifiers (openFDA)
- Application number
- ANDA040319
- Brand name
- DICYCLOMINE HYDROCHLORIDE
- Generic name
- DICYCLOMINE HYDROCHLORIDE
- Manufacturer name
- Aurobindo Pharma Limited
- Product NDC
- 59651-719
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- DICYCLOMINE HYDROCHLORIDE
- RxCUI
- 991061
- SPL ID
- ec746016-eed0-4e37-bb9c-cb430c8a7f07
- SPL set ID
- ec746016-eed0-4e37-bb9c-cb430c8a7f07
- Package NDC
- 59651-719-01, 59651-719-99
- Is original packager
- true
- Upc
- 0359651719015
- UNII
- CQ903KQA31