Why it was recalled
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Product description
Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack)
Lot numbers, UPCs & expiration codes
Lot: 17F28AA, Exp 1/2020
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-1207-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 7, 2018
- FDA report date
- Dec 26, 2018
- Quantity
- 47,520 prescription packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-1207-2019, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81765
- Address
- 270 Prospect Plains Rd
- Code information
- Lot: 17F28AA, Exp 1/2020
- Postal code
- 08512-3605
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-1207-2019
- Classification
- Class III
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 47,520 prescription packs
- Termination date
- Jun 14, 2019
- Reason for recall
- Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack)
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 7, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 22, 2019