Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported December 27, 2017
Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Premier Pharmacy Labs Inc recalled Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hosp… - a moderate-severity action.
Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hosp… was recalled by Premier Pharmacy Labs Inc in December 27, 2017. Reason: Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stabi…. Check the official notice for the remedy. Verify recall #D-0129-2018 with the FDA Drug before acting.
The recall
Premier Pharmacy Labs Inc issued this moderate-severity FDA Drug recall-Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stabi….
- Moderate
- severity level
- Class II
- classification
- December 27, 2017
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0129-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0129-2018) was formally reported on December 27, 2017, with the manufacturer initiating the action on August 10, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Premier Pharmacy Labs Inc is listed as the recalling firm, operating out of Weeki Wachee, FL. Federal records list the affected scope as 1610 syringes.
The documented reason for this recall is: Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data. Distribution data in the federal record shows the product reached: Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1610 syringes
Related Recalls
6
0 from same agency
Product description
Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15
Reason for recall
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0129-2018 |
| Date reported | December 27, 2017 |
| Date initiated | August 10, 2017 |
| Recalling firm | Premier Pharmacy Labs Inc |
| Firm location | Weeki Wachee, FL |
| Affected scope | 1610 syringes |
| Distribution | Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0129-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15. Recalled by Premier Pharmacy Labs Inc. Units affected: 1610 syringes.
Why was this product recalled? ▼
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 27, 2017. Severity: Moderate. Recall number: D-0129-2018.
Where was the recalled product distributed? ▼
Distribution: Michigan, Maryland, Minnesota, North Carolina, Ohio, Florida.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0129-2018) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 27, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.