Recalls / Class III
Class IIID-1207-2019
Product
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)
- Brand name
- Absorica Ld
- Generic name
- Isotretinoin
- Active ingredient
- Isotretinoin
- Route
- Oral
- NDCs
- 10631-002, 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 10631-003, 10631-004, 10631-005 +2 more
- FDA application
- NDA211913
- Affected lot / code info
- Lot: 17F28AA, Exp 1/2020
Why it was recalled
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 47,520 prescription packs
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-12-07
- FDA classified
- 2019-04-22
- Posted by FDA
- 2018-12-26
- Terminated
- 2019-06-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1207-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.