FDA Drug recall D-1109-2022
Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset Therapeutics, Inc., NDC 7006919101
- FDA Drug
- Class II
- terminated
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset Therapeutics, Inc., NDC 7006919101 by Mckesson Medical Surgical Corporate Office, citing cGMP deviations: Temperature abuse.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1109-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-13 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | US |
Product
Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset Therapeutics, Inc., NDC 7006919101
Reason
cGMP deviations: Temperature abuse
Identifiers
| code_info | McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee fo…McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1109-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.