PlainRecordsFDA · Drug recall
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine… and 1 more product
- Date
- Nov. 3, 2021
- Risk class
- Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)
- Status
- Terminated
- Filed by
- Sun Pharmaceutical Industries Inc
- Reason
- Failed Moisture Limits
- Distribution pattern
- Nationwide within the United States
2 products in this recall
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate…
- Product
- Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15
- Quantity
- 22,752 blister packs
- Codes and lots
- Lot #: AC14635, Exp. Date 12/2022
- Recall started
- Oct. 12, 2021
- Recall number
- D-0068-2022
AllerClear D-24 hr…
- Product
- AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15
- Quantity
- 46,584 blister packs
- Codes and lots
- AC09723, Exo, Date 11/2022
- Recall started
- Oct. 12, 2021
- Recall number
- D-0069-2022
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement reports, recall numbers D-0068-2022, D-0069-2022. The agency record governs; check it and the company before acting.