CALCIUM CHLORIDE Recall D-1033-2022
Description: BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-15
CALCIUM CHLORIDE Recall D-1033-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1033-2022 |
| Event ID | 89646 |
| Brand | BSS |
| Generic Name | BALANCED SALT SOLUTION |
| Manufacturer | BALANCED SALT SOLUTION |
| Original Package? | 1 |
| Active Substance | CALCIUM CHLORIDE MAGNESIUM CHLORIDE |
| Drug Route | OPHTHALMIC |
| Distribution | USA nationwide. |
| Quantity | 13 bottles |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0065-0795 |
| Drug UPC | 0300650795159 |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | M4I0D6VV5M 02F3473H9O |
| Drug Application Number | NDA020742 |
| Structured Product Labeling (SPL ID) | 82defe39-5cf0-4928-acaa-2a597a1c9641 |
| Structured Product Labeling (SPL Set ID) | 4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea |
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